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GnRh Antagonist Protocol With Delayed Start Stimulation in Patients With Poor Ovarian Response

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ClinicalTrials.gov Identifier: NCT03134690
Recruitment Status : Unknown
Verified December 2016 by Royan Institute.
Recruitment status was:  Recruiting
First Posted : May 1, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Royan Institute

December 19, 2016
May 1, 2017
May 1, 2017
January 2016
April 2017   (Final data collection date for primary outcome measure)
  • number of dominant follicles (≥13 mm) [ Time Frame: 24h after rhCG injection ]
    The number of dominant follicles (≥13 mm) on the day of hCG trigger
  • Total number of oocytes [ Time Frame: 32-34 hours after rhCG ]
    the number of mature oocytes collected after conventional versus delayed-start ovarian stimulation protocol
Same as current
No Changes Posted
  • Total number of retrieved oocytes [ Time Frame: 32-34 hours after rhCG injection ]
    Total number of retrieved oocytes 32-34 hours after rhCG injection .
  • Quality of obtained embryos [ Time Frame: on the third day after oocyte retrieval ]
    we score embryo quality according to the following quality criteria: Excellent (Day 3: 6-8 even size blastomeres with ≤10% fragmentation), Good (Day 3: 6-8 even or uneven size blastomeres with 10%-20% fragmentation), Poor (Uneven and few blastomeres with >20% fragmentation)
Same as current
Not Provided
Not Provided
 
GnRh Antagonist Protocol With Delayed Start Stimulation in Patients With Poor Ovarian Response
Evaluation of a Novel " Delayed Start" Protocol With Gonadotropin-releasing Hormone Antagonist in Poor Responders: A Randomized Clinical Trial Phase 3
The main outcome measures are the number of dominant follicles (≥13 mm) on the day of hCG trigger and the number of mature (MII) oocytes collected after conventional versus delayed-start ovarian stimulation protocol. Secondary outcome measures are including total number of oocytes retrieved, oocyte maturity rate (number of MII oocytes/total number of oocytes), oocyte yield (total number of oocytes retrieved/ antral follicle count [AFC]), mature oocyte yield (number of mature oocytes retrieved/AFC), total dosage of gonadotropin (recombinant FSH and/or highly purified hMG) needed, number of days needed for ovarian stimulation, quality of obtained embryos, fertilization rate (the proportion of total number of two-pronuclear [2PN] stage zygotes /per total injected MII oocytes), implantation rate (total number of observed gestational sac/ number of transferred embryos) and clinical pregnancy rate (presence of fetal heart beat by transvaginal ultrasound per embryo transfer).

One of the principal steps to obtain the favorable success is still related to the number of retrieved oocytes after hormonal stimulation by gonadotropins in combination with GnRH analogues. In the patients with "poor ovarian response" diagnosis, the limited number of obtained oocytes remains the main obstacle in optimizing the live birth rates. The objective of present study is to evaluate a new procedure to increase a cohort of the growing antral follicles and consequently the number of retrieved oocytes after hormonal stimulation by gonadotropins in combination with GnRH antagonist. In present study, eligible patients with diagnosis poor ovarian responder based on the Bologna criteria are included. Ovarian stimulation procedure will be performed by antagonist protocol. All the patients will be received two tablets daily of Estradiol valerate (Estraval®, 2 mg, Aburaihan Co., Tehran, Iran) starting a week after LH surge until menses. The hormonal evaluation (serum LH and FSH) and basic vaginal ultrasound will be performed before the starting ovarian stimulation on the 2th or 3th day of the menstrual cycle. On this day, the block randomization method will be designed to randomize allocation of patients into groups with blocks of size 4.

In the Group A: treatment with GnRH antagonists (Cetrotide®, 0.25 mg cetrorelix acetate, Serono, Inc) will be started on the 2th or 3th day of the menstrual cycle and continues until the ninth day. Then, the ovarian stimulation with gonadotropin 300 IU recombinant FSH (Gonal - F®, Serono Laboratories Ltd, Geneva, Switzerland) and 150 IU of hMG (Menopur®; Ferring) will be started from ninth day of menstrual cycle until the day of hCG administration. The monitoring of ovarian stimulation will be done every other day by vaginal ultrasound and whenever at least 1 to 3 follicles larger than 13 mm are observed, the antagonist injection (Cetrotide®, 0.25 mg cetrorelix acetate, Serono, Inc) will be started again to prevent premature LH surge and continues until the prescription of hCG. When at least two follicles greater than 17 to 18 mm is seen, two pre-filled syringes of recombinant human chorionic gonadotropin (rhCG) (Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) will be administered. The patients will undergo puncture operation 32-34 hours after hCG injection.

In the control group (B), as conventional antagonist procedure, the ovarian stimulation with gonadotropin 300 IU recombinant FSH (Gonal - F®, Serono Laboratories Ltd, Geneva, Switzerland) and 150 IU of hMG ( Menopur®; Ferring ) will be started from on the 2th or 3th day of the menstrual cycle. The monitoring of ovarian stimulation will be done every other day by vaginal ultrasound and whenever at least 1 to 3 follicles larger than 13 mm are observed, the antagonist injection (Cetrotide®, 0.25 mg cetrorelix acetate, Serono, Inc) will be started again to prevent premature LH surge and continues until the prescription of rhCG. 32-34 hours after the rhCG injection, the ovum pick up will be performed and subsequently intracytoplasmic sperm injection (ICSI) /in-vitro fertilization (IVF) will be done for all the patients.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Infertility, Female
  • Procedure: delayed start
    In this protocol, ovarian stimulation will be started from ninth day of menstrual cycle .
  • Procedure: Conventional
    In this protocol, ovarian stimulation will be started from the 2th or 3th day of the menstrual cycle.
  • Experimental: delayed start antagonist
    30 women with f poor ovarian responses undergo ovarian stimulation with delayed start antagonist.
    Intervention: Procedure: delayed start
  • Experimental: conventional antagonist
    30 women with diagnose of poor ovarian response will have undergone ovarian stimulation with conventional antagonist protocol.
    Intervention: Procedure: Conventional
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
May 2017
April 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • a history of ovarian surgery;
  • previous treatment using conventional protocols that yielded less than three oocytes;
  • antral follicle count of less than 5 on menstrual cycle day 2-3; and basal serum FSH concentration between 10 and 19 IU/l.

Exclusion Criteria:

  • ovarian failure including basal FSH above 20 IU/l or no antral follicle by ultrasound examination;
  • Endometriosis grade 3 or higher;
  • Any contraindications to ovarian stimulation treatment.
Sexes Eligible for Study: Female
40 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT03134690
Royan-Emb-028
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Royan Institute
Royan Institute
Not Provided
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Mahnaz Ashrafi, MD Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Principal Investigator: Mandana Hemmat, MD Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Principal Investigator: Arezoo Arabipour, MSc Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Royan Institute
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP