NCT04600986

Brief Summary

This is a prospective, randomized, proof-of-concept study, designed to compare the IVF results in patients diagnosed with polycystic ovarian syndrome (PCOS) defined as per the ESHRE/ASRM Rotterdam criteria (2003) undergoing in-vitro fertilization/ intracytoplasmic sperm injection (IVF/ICSI) in antagonist protocol. Patients were randomized into two groups. Group A: single dose of GnRHa 0.2 mg, 35 h prior to oocyte retrieval, and Group B: 0.2 mg GnRHa 35 h prior to oocyte retrieval + a repeat dose of 0.1 mg 12 h following the 1st dose. 12 h post-trigger, luteinizing hormone (LH), progesterone (P4) values will be estimated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

October 19, 2020

Last Update Submit

February 6, 2023

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (2)

  • Oocyte maturity rate

    Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in the patients undergoing with ICSI.

    24 hours post oocyte retrieval day

  • Oocyte yield

    Oocyte yield was defined as the ratio of the total number of collected oocytes to the number of follicles measuring ≥10 mm on the day of oocyte retrieval.

    34 to 36 hours post the first trigger with GnRHa

Secondary Outcomes (7)

  • Fertilization rate

    48 hours post IVF/ICSI

  • Number and grading of blastocysts

    1 week after oocyte retrieval

  • Post-trigger serum luteinizing hormone (LH)

    12 hours post trigger with the first injection of GnRHa

  • Post-trigger serum progesterone (P4)

    12 hours post trigger with the first injection of GnRHa

  • Implantation rate

    1 month post embryo transfer

  • +2 more secondary outcomes

Study Arms (2)

New oocyte triggering

EXPERIMENTAL

The final oocyte maturation will be triggered with a single dose of 0.2 mg s.c triptorelin (decapeptyl) and in addition a repeat dose of 0.1 mg s.c triptorelin (decapeptyl) will prescribed 12 h following the first dose.

Other: Repeated dose of GnRH agonist

Routine oocyte trigering

OTHER

The final oocyte maturation will be triggered with a single dose of 0.2 mg s.c triptorelin (decapeptyl), 35 h prior to oocyte retrieval.

Other: Repeated dose of GnRH agonist

Interventions

Repeated dose of GnRH agonistOTHER

0.2 mg triptorelin plus a repeat dose of 0.1 mg 12 hours following the first dose.

New oocyte triggeringRoutine oocyte trigering

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All PCOS patients defined as per the ESHE/ASRM Rotterdam criteria undergoing ovarian stimulation for IVF/ICSI using GnRH antagonist protocol:
  • Anticipated high ovarian response (serum E2\> 3000 on trigger day)
  • Body mass index (BMI) \>18 and \<35 kg/m2
  • Willingness to participate in the study

You may not qualify if:

  • Severe male factor infertility
  • Patients with severe endometriosis
  • Donor cycles
  • Indication for preimplantation genetic diagnosis
  • Uterine abnormality or existing myoma greater than 5cm
  • couple's drug addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

  • Hashemi SH, Hafezi M, Arabipoor A, Zareei M, Vesali S, Eftekhari-Yazdi P. Can We Harvest More Mature Oocytes by Repeating Gonadotropin-Releasing Hormone Agonist Doses in Polycystic Ovarian Syndrome Patients at Risk of OHSS in Antagonist Cycles? A Randomised Clinical Trial. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):48-54. doi: 10.22074/ijfs.2023.2008905.1513.

    PMID: 39033370DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Maryam Hafezi, MD.

    Department of Endocrinology and Female Infertility, Royan Institute

    STUDY DIRECTOR

  • Hoora Hashemi, MD.

    Department of Endocrinology and Female Infertility, Royan Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2020

First Posted

October 23, 2020

Study Start

May 30, 2020

Primary Completion

June 30, 2022

Study Completion

September 30, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)