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

NCT03134690 | Completed DMC

• 1 other identifier: Royan-Emb-028
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Infertility, Female

Keywords

Poor ovarian response gonadotropins antagonist

Outcome Measures

Primary Outcomes (2)

• number of dominant follicles (≥13 mm)

  The number of dominant follicles (≥13 mm) on the day of hCG trigger

  24h after rhCG injection

• Total number of oocytes

  the number of mature oocytes collected after conventional versus delayed-start ovarian stimulation protocol

  32-34 hours after rhCG

Secondary Outcomes (2)

• Total number of retrieved oocytes

  32-34 hours after rhCG injection

• Quality of obtained embryos

  on the third day after oocyte retrieval

Study Arms (2)

delayed start antagonist

EXPERIMENTAL

60 women with poor ovarian responses undergo ovarian stimulation with delayed start antagonist.

Procedure: delayed start

conventional antagonist

EXPERIMENTAL

60 women with diagnose of poor ovarian response will have undergone ovarian stimulation with conventional antagonist protocol.

Procedure: Conventional

Interventions

delayed start PROCEDURE

In this protocol, ovarian stimulation will be started from ninth day of menstrual cycle .

delayed start antagonist

Conventional PROCEDURE

In this protocol, ovarian stimulation will be started from the 2th or 3th day of the menstrual cycle.

conventional antagonist

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Premature ovarian failure (basal follicle stimulating hormone (FSH) above 20 IU/l or no antral follicle in ultrasound examination),
• ِDonor/recipient treatments,
• Metabolic or endocrine disorders including hyperprolactinoma and hypo/hyperthyroidism, endometriosis,
• Body mass index \> 30 kg/m2,
• azoospermic male partner.
• A minimum of 2 or more month's interval from the previous ovarian stimulation is considered to prevent any potential source of error.

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

• Ashrafi M, Arabipoor A, Yahyaei A, Zolfaghari Z, Ghaffari F. Does the "delayed start" protocol with gonadotropin-releasing hormone antagonist improve the pregnancy outcome in Bologna poor responders? a randomized clinical trial. Reprod Biol Endocrinol. 2018 Dec 28;16(1):124. doi: 10.1186/s12958-018-0442-y.

  PMID: 30593268 DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Mahnaz Ashrafi, MD

  Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, ACECR, Tehran, Iran

  STUDY DIRECTOR

• Mandana Hemmat, MD

  Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, ACECR, Tehran, Iran

  PRINCIPAL INVESTIGATOR

• Arezoo Arabipour, MSc

  Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, ACECR, Tehran, Iran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: May 1, 2017
• Study Start: January 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)