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Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality

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ClinicalTrials.gov Identifier: NCT03139474
Recruitment Status : Not yet recruiting
First Posted : May 4, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Traiza Helal, Assiut University

Brief Summary:

The first In-Vitro Fertilization cycles were performed in natural unstimulated cycles. Today gonadotrophins are administered to induce multiple follicular development and controlled ovarian hyperstimulation. During ovarian stimulation gonadotrophin-releasing hormone analogues are co-administered in order to prevent premature luteinizing hormone surges. Premature luteinizing hormone surges are observed in about 20% of stimulated cycles without using gonadotrophin-releasing hormone analogues .

Avoiding the adverse effects of elevated luteinizing hormone levels, first gonadotrophin-releasing hormone agonist analogues were used to supplement the gonadotrophin stimulation. The continuous administration of gonadotrophin-releasing hormone agonists causes gonadotrophin suppression through down-regulation and desensitization of the gonadotrophin-releasing hormone receptors in the pituitary gland after an initial short period of gonadotrophin hypersecretion .

Gonadotrophin-releasing hormone antagonists (cetrorelix and ganirelix) cause immediate and rapid gonadotrophin suppression by competitive antagonism of the gonadotrophin-releasing hormone receptor in the pituitary without an initial period of gonadotrophin hypersecretion. Several advantageous effects of cetrorelix were established , and these effects seemed to be independent from the type of antagonist used for luteinizing hormone-suppression.The quality of oocytes and developing preembryos is one of the most relevant factors determining the success of an In-Vitro Fertilization treatment. As ovarian stimulation protocol is one of the eligible factors during an In-Vitro Fertilization treatment, its embryo quality influencing effects are necessary to know.


Condition or disease Intervention/treatment Phase
Infertility, Female Drug: Gonadotropin-Releasing Hormone Analogue Drug: Gonadotropin releasing hormone antagonist Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality in Intracytoplasmic Sperm Injection Cycles.
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: agonist group
Triptorelin at a dose 1 milligram per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation.
Drug: Gonadotropin-Releasing Hormone Analogue
Triptorelin at a dose 1 mg per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation.
Active Comparator: antagonist group
•Multiple dose Gonadotrophin releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter .
Drug: Gonadotropin releasing hormone antagonist
antagonist group :Multiple dose gonadotrophin-releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter .We will give them gonadotrophin for 5 days , Triggering by Human Chorionic Gonadotrophin will be administered for each group when size of follicle reach > 17 millimeter .Oocytes will retrieved by transvaginal ultrasound , 34-36 hours after Human Chorionic Gonadotrophin administration .



Primary Outcome Measures :
  1. number of maturated oocyte and good quality embryoes [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. clinical pregnancy outcome [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Unexplained infertility.
  2. Tubal factor. Included treated hydrosalpinx and pyosalpinx
  3. first cycle .
  4. Body mass index: 18-29.
  5. Follicle stimulating hormone not more than 14 , E2 not more than 80 and Antimullerian hormone >1.
  6. Antral follicular count: more than 5 follicles in one ovary.
  7. combined factors .
  8. Normal male semen analysis: Mild male factor: concentrations 10 million - 20 million sperm/ml. Moderate male factor : concentrations 5 million - 10 million sperm/ml.

Exclusion Criteria:

  1. Patients with Endometriosis.
  2. Azoospermic male.
  3. Body mass index more than 29.

Responsible Party: Traiza Helal, Dr., Assiut University
ClinicalTrials.gov Identifier: NCT03139474     History of Changes
Other Study ID Numbers: HYY
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Hormones
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs