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Trial record 11 of 12 for:    Premature Ovarian Failure 14

Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility (CS-EOSP-ICSI)

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ClinicalTrials.gov Identifier: NCT04071574
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Nehman Makdissy, Lebanese University

Brief Summary:
The study will describe the effectiveness of ovarian stimulation in correlation with female infertility causes in a Lebanese population: a comparative study using 5 protocols of ovulation induction (treatment with "A" gonadotropins alone, "B" short GnRH agonist, "C" multiple-dose GnRH antagonist, "D" long GnRH agonist and "E" combined protocol of GnRH antagonist and agonist) and the outcomes of ICSI. This comparative study will help clinicians to select the relevant protocol of ovarian stimulation related to the female infertility disorders.

Condition or disease Intervention/treatment Phase
Female Infertility Female Infertility Due to Ovulatory Disorder Premature Ovarian Failure Polycystic Ovary Syndrome Female Infertility of Tubal Origin Ectopic Pregnancy Salpingitis Female Infertility Due to Tubal Block Female Infertility Due to Tubal Occlusion Hydrosalpinx Female Infertility - Cervical/Vaginal Female Infertility Endocrine Endometriosis Fibroids Congenital Uterine Anomaly Infections Uterine Female Infertility of Other Origin Drug: Human Chorionic Gonadotropin (hCG) Drug: Gonadotropins Drug: GNRH-A Triptorelin Drug: GnRH antagonist Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: comparative protocols
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Women With Infertility Problems
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : August 22, 2019
Estimated Study Completion Date : December 30, 2019


Arm Intervention/treatment
Active Comparator: Protocol "A"

Protocol with gonadotropins alone without agonist or antagonist:

Gonadotropin treatment begins after spontaneous menses. The gonadotropins (e.g. Menopur, 150-225IU) are injected daily from D2/3 of the cycle (Gonadotropin dose varies based on the follicular response). The moment to trigger ovulation by administration of HCG (e.g. Ovitrelle or Pregnyl, 10.000IU) is determined by monitoring ovulation (folliculogenesis) approximately 14 days after gonadotropins regimen and the presence of at least 3 follicles with 18 mm sizes and at least the levels of E2 reaches 250-300 pg/ml. 36 h after HCG triggering, the mature oocytes are retrieved.

Drug: Human Chorionic Gonadotropin (hCG)
Administration of hCG (10.000IU) for ovulation triggering
Other Name: OVITRELLE / PREGNYL

Drug: Gonadotropins
Administration of Menotropin (hMG / FSH and LH at a 1:1 ratio) (150-225IU/day)
Other Name: MENOPUR

Active Comparator: Protocol "B"

Short GnRH agonist protocol:

For the short GnRH agonist protocol, the administration of gonadotropins begins at the same time as that of the agonist, which makes it possible to take advantage of the action of endogenous gonadotropins released by the flare-up effect of the agonist. A low dose of GnRH agonist (e.g., triptorelin (Decapeptyl 0.1mg/day)) is administered in parallel to gonadotropin (e.g. Menopur, 150-225 IU) daily starting on cycle-day 2 (Gonadotropin dose varies based on the follicular development). Continual administration of GnRH agonist and gonadotropin lasts until HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU), ~14 days post GnRH agonist regimen when follicles size reached 16-18 mm and at least the levels of E2 reaches 250-300 pg/ml. 36 h after HCG triggering, the mature oocytes are retrieved.

Drug: Human Chorionic Gonadotropin (hCG)
Administration of hCG (10.000IU) for ovulation triggering
Other Name: OVITRELLE / PREGNYL

Drug: Gonadotropins
Administration of Menotropin (hMG / FSH and LH at a 1:1 ratio) (150-225IU/day)
Other Name: MENOPUR

Drug: GNRH-A Triptorelin
Administration of Triptorelin (0.1mg/day)
Other Name: DECAPEPTYL

Active Comparator: Protocol "C"

Multiple-dose antagonist protocol:

For the GnRH antagonist protocol, a low dose of GnRH antagonist (0.25 mg/day) is administered. The protocol starts with the administration of gonadotropin (e.g. Menopur, 150-225 IU) daily which is initiated after monitoring of patients' follicles sizes on cycle-day 2/3 (Gonadotropin dose varies based on the follicular response). Almost after the 6th days of gonadotropin injection or when follicular size reaches more than or equal to 14 mm, GnRH antagonist (e.g., cetrorelix (cetrotide) or ganirelix (orgulatron) 0.25mg) begins by subcutaneous administration every day till HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU). 36 h after HCG triggering, the mature oocytes are retrieved.

Drug: Human Chorionic Gonadotropin (hCG)
Administration of hCG (10.000IU) for ovulation triggering
Other Name: OVITRELLE / PREGNYL

Drug: Gonadotropins
Administration of Menotropin (hMG / FSH and LH at a 1:1 ratio) (150-225IU/day)
Other Name: MENOPUR

Drug: GnRH antagonist
Administration of cetrorelix (cetrotide) or ganirelix (orgulatron) (0.25mg/day)
Other Name: CETROTIDE / ORGULATRON

Active Comparator: Protocol "D"

Long GnRH agonist protocol:

For the long GnRH agonist protocol, a low dose of GnRH agonist (e.g., triptorelin (Decapeptyl 0.1mg)) is administered on cycle-day 21 followed by gonadotropin (e.g. Menopur, 150-225 IU) daily starting on cycle-day 2 after menses (Gonadotropin dose varies based on the follicular development). Continual administration of GnRH agonist and gonadotropin lasts until HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU), ~14 days post GnRH agonist regimen when follicles size reached 16-18 mm. 36 h after HCG triggering, the mature oocytes are retrieved.

Drug: Human Chorionic Gonadotropin (hCG)
Administration of hCG (10.000IU) for ovulation triggering
Other Name: OVITRELLE / PREGNYL

Drug: Gonadotropins
Administration of Menotropin (hMG / FSH and LH at a 1:1 ratio) (150-225IU/day)
Other Name: MENOPUR

Drug: GNRH-A Triptorelin
Administration of Triptorelin (0.1mg/day)
Other Name: DECAPEPTYL

Active Comparator: Protocol "E"

Combined GnRH antagonist and agonist protocol:

For the combined protocol, it starts with the administration of gonadotropin (e.g. Menopur, 150-225 IU) daily which is initiated after monitoring of patients' follicles sizes on cycle-day 2/3 (Gonadotropin dose varies based on the follicular response). Almost after the 6th days of gonadotropin injection or when follicular size reaches more than or equal to 14 mm, GnRH antagonist (e.g., cetrorelix (cetrotide) or ganirelix (orgulatron) 0.25mg) begins by subcutaneous administration every day till GnRH agonist injection (e.g., triptorelin (Decapeptyl 0.1mg/day)). 36 h after agonist injection, the mature oocytes are retrieved.

Drug: Gonadotropins
Administration of Menotropin (hMG / FSH and LH at a 1:1 ratio) (150-225IU/day)
Other Name: MENOPUR

Drug: GNRH-A Triptorelin
Administration of Triptorelin (0.1mg/day)
Other Name: DECAPEPTYL

Drug: GnRH antagonist
Administration of cetrorelix (cetrotide) or ganirelix (orgulatron) (0.25mg/day)
Other Name: CETROTIDE / ORGULATRON




Primary Outcome Measures :
  1. Ovulation Induction [ Time Frame: 36 hours ]
    Monitoring of Ovulation Stimulation by trans-vaginal ultrasound determining the growth, number and appearance of the ovarian follicles as well as the maturation of the endometrium (measurement of its thickness); Follicles are considered mature when their diameter is greater than 18-20mm and each of them provides 250-300pg/mL of E2. When these criteria are obtained, ovulation is triggered


Secondary Outcome Measures :
  1. fertilization rate [ Time Frame: 12 months ]
    Changes in the fertilization rate

  2. embryo quality [ Time Frame: 12 months ]
    Selection of embryos for transfer depending on their morphology, and the regularity of blastomers

  3. pregnancy rate [ Time Frame: 12 months ]
    Determination of βHCG for positive results

  4. live birth rate [ Time Frame: 12 months ]
    Calculations of live birth rate are based on the number of live births in each group divided by all live births, multiplied by 100



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The average age of the population must be around 30 years old. Note that no one of the 264 women in this study should have any chromosomal abnormalities or mutated genes that affect ovarian function.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must not show any of the excluded criteria
  • Patients affected by female infertility due to particularly Ovulatory Disorder, Premature Ovarian Failure, Polycystic Ovary Syndrome, Tubal Origin, Ectopic Pregnancy, Salpingitis, Tubal Block/Occlusion, Hydrosalpinx, Cervical/Vaginal, Endocrine, Endometriosis, Fibroids, Congenital Uterine Anomaly, Infections Uterine, and Female Infertility of Other Origin
  • The selection of subjects' age must be group matched between protocols of treatment. Premature ovarian failure is defined as AMH (Anti Mullerian Hormone) ≤ 2 ng/mL.
  • Willing to collaborate and to attend to the clinical follow-ups for the next three years
  • Patients willing to sign informed consent
  • Able and willing to comply with all study requirements
  • Absence of genetic causes
  • Medically suitable to undergo ovarian stimulation
  • Normal serum chemistry and hematology screening tests
  • Negative human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) serology
  • No history of malignancy
  • Complete history & physical examination

Exclusion Criteria:

  • Subjects to be excluded from the study if the male (husband) had any male infertility problem(s)
  • Patients with any genetic abnormalities
  • Patients with histories of neurologic conditions including moderate or severe head injury, stroke, cerebral or bone damage or malignancies, brain abnormalities, learning disability, major medical or psychiatric illness, and metabolic/cardiovascular disease or evidence of cardiac/renal damage or malignancies, alcohol, loss of weight during the last 2 years, chemotherapy or immunosuppressive therapy.
  • Women aged 45 years and older, under 21 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071574


Contacts
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Contact: Nehman Makdissy, Professor +96171210250 almakdissy@hotmail.com
Contact: Samar El Hamoui, Dr +9613246315 simcima@ymail.com

Locations
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Lebanon
Lebanese University, faculty of sciences III Recruiting
Tripoli, North Lebanon, Lebanon, 961
Contact: Nehman Makdissy, Professor         
Sponsors and Collaborators
Lebanese University
Investigators
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Study Chair: Nehman Makdissy, Professor Lebanese University
Study Director: Samar El Hamoui, Dr Lebanese University

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Responsible Party: Nehman Makdissy, Professor, Lebanese University
ClinicalTrials.gov Identifier: NCT04071574     History of Changes
Other Study ID Numbers: LU-MC-001/18
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nehman Makdissy, Lebanese University:
Infertility; Ovarian; Ovulation; IVF; ICSI; Gonadotropin
Additional relevant MeSH terms:
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Primary Ovarian Insufficiency
Menopause, Premature
Ovarian Cysts
Ovarian Diseases
Polycystic Ovary Syndrome
Infertility
Endometriosis
Infertility, Female
Pregnancy, Ectopic
Salpingitis
Genital Diseases, Male
Genital Diseases, Female
Cysts
Neoplasms
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Pregnancy Complications
Fallopian Tube Diseases
Pelvic Inflammatory Disease
Triptorelin Pamoate
Chorionic Gonadotropin
Cetrorelix
Menotropins
Prolactin Release-Inhibiting Factors
Ganirelix
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Luteolytic Agents