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Second Step Protocol in Poor Ovarian Responder (POR) (POR)

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ClinicalTrials.gov Identifier: NCT03480412
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Antonia Iacovelli, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Brief Summary:

Reduced ovarian reserve and the consequent poor ovarian response are very recurent in infertile patients, indeed a percentage of 10%-24% of couples addressed to infertility program may be classified as Poor Ovarian Responder (POR).

Objective: To evaluate whether the repeated luteal phase stimulation (Second Step) permits a significantly higher number of oocytes retrieved in POR when compared to conventional follicular stimulation.

Interventions: The follicular phase stimulation is conduced according to a standardized Antagonist protocol or Short protocol (with GnRH agonist) using recombinant or urinary gonadotropins (starting dose 300 or 450 UI) or a long lasting recombinant gonadotropin (Corifollitropin alfa 150 mcg).

Two - six days after the first oocyte retrieval a second gonadotropin stimulation will be started with a GnRH antagonist protocol (the stimulation will be started with 250 UI of human menopausal gonadotropin (hMG) and a GnRH antagonist (GnRH-an) 0,25 mg\die will be administered when the leading follicle is ≥ 14 mm until hCG (human chorionic gonadotropin) criteria are met. When at least two follicles had reached 17-18 mm in diameter, ovulation will be triggered with a single subcutaneous bolus of urinary human chorionic gonadotropin (10.000 UI ) and oocyte retrieval will be performed after 35 hours.

Two or Three months after the second oocyte retrieval the Embryo transfer (ET) will be performed after endometrial preparation with Estradiol Valerate and intramuscular Progesterone.


Condition or disease Intervention/treatment
Infertility, Female Premature Ovarian Failure Fertility Disorders Procedure: Follicular Phase Procedure: Luteal Phase

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Repeated Luteal Phase Ovarian Stimulation (Second Step Protocol) in Poor Responder Patients
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Follicular Phase Procedure: Follicular Phase
The follicular phase stimulation is conduced according to a standardized Antagonist protocol or Short protocol (with GnRH agonist) using recombinant or urinary gonadotropins (starting dose 300 or 450 UI) or a long lasting recombinant gonadotropin (Corifollitropin alfa 150 mcg) from the second day of the menstrual cycle. When at least two follicles had reached 17-18 mm in diameter, ovulation will be triggered with a single subcutaneous bolus of urinary human chorionic gonadotropin (10.000 UI ) and oocyte retrieval will be performed after 35 hours.
Other Name: First Step

Luteal Phase Procedure: Luteal Phase
Two - six days after the first oocyte retrieval a second gonadotropin stimulation will be started with a GnRH antagonist protocol (the stimulation will be started with 250 UI of human menopausal gonadotropin (hMG) and a GnRH antagonist (GnRH-an) 0,25 mg\die will be administered when the leading follicle is ≥ 14 mm until hCG criteria are met). When at least two follicles had reached 17-18 mm in diameter, ovulation will be triggered with a single subcutaneous bolus of urinary human chorionic gonadotropin (10.000 UI ) and oocyte retrieval will be performed after 35 hours.
Other Name: Second Step




Primary Outcome Measures :
  1. Number of oocyte Retrieved [ Time Frame: 15 days after the Second oocyte retrieval ]
    Number of oocyte Retrieved after the first oocyte retrieval vs Number of oocyte Retrieved after the second oocyte retrieval


Secondary Outcome Measures :
  1. Number of Embryos Obtained [ Time Frame: 15 days after the Second oocyte retrieval ]
    Number of Embryos Obtained after the Follicular Phase Stimulation and intracytoplasmic sperm injection vs Number of Embryos obtained after Luteal Phase Stimulation and intracytoplasmic sperm injection



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women classified like Poor Ovarian Responder
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infertil Women classified as Poor Ovarian Responder according with Bologna Criteria (2011) for which an IVF is indicated and in which the number of oocyte retrieved with First oocyte retrieval ≤ 2
Criteria

Inclusion Criteria:

  • Antral Follicular Count ≤7 follicles
  • Number of oocyte retrieved with First oocyte retrieval ≤ 2

Exclusion Criteria:

  • Antral follicular Count < 7
  • Anti-Müllerian hormone (AMH) >1.1 ng \mL
  • Number of oocyte retrieved with First oocyte retrieval > 2
  • Absence of antral follicles after First oocyte retrieval

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): NCT03480412


Contacts
Contact: Antonia Iacovelli, Doctor +393203595229 antonia.iacovelli.med@gmail.com
Contact: Gian Mario Tiboni, Professor +393478787545 tiboni@unich.it

Locations
Italy
Ospedale G. Bernabeo Recruiting
Ortona, Chieti, Italy, 66026
Contact: Antonia Iacovelli, Doctor    3203595229    antonia.iacovelli.med@gmail.com   
Sponsors and Collaborators
Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Responsible Party: Antonia Iacovelli, Doctor, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
ClinicalTrials.gov Identifier: NCT03480412     History of Changes
Other Study ID Numbers: Second Step 1
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonia Iacovelli, Università degli Studi 'G. d'Annunzio' Chieti e Pescara:
Luteal Phase Stimulation
Poor Ovarian Response
In Vitro Fertilization

Additional relevant MeSH terms:
Infertility
Infertility, Female
Chorionic Gonadotropin
Primary Ovarian Insufficiency
Menopause, Premature
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Reproductive Control Agents
Physiological Effects of Drugs