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NCT Number: NCT02496754

Follicular Long GnRH Agonist Versus Antagonist Protocol in PCOS Women Undergoing in Vitro Fertilization

Pituitary down regulation is widely used during in vitro fertilization (IVF) procedures. It can suppress the spontaneous luteinizing hormone (LH) surge, and can also make follicles growth evenly.

At present, standard gonadotropin releasing hormone analogue (GnRH-a) long protocol is used in arou Long term GnRH-a, which is usually used in patients with endometriosis,has been shown to increase IVF outcome by altering endometrial receptivity. Moreover, it is also very convenient because patients do not have to inject GnRH-a daily. In order to make patients feel more comfortable during IVF treatment, the investigators have used a new ovarian stimulation protocol since the beginning of 2015. The investigators give patients long term GnRH-a (3.75mg) once at menstrual cycle D2, and begin the use of Gn to stimulate follicle growth around 30 days later based on the hormone levels and follicle size. In the pilot observational study of several patients, no LH surge occurred during ovarian stimulation.

The aim of this randomized controlled study is to compare the efficiency of this new protocol and standard GnRH-a long protocol in the investigator's center.

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Key information

Conditions

Clinical Pregnancy Rate IVF Ovulation Induction

Age range

22 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

About this study

The primary outcome is clinical prengancy rate. Secondary outcome is cumulative live birth rate. Other parameters include number of oocytes retrieved, 2 pronucleus (2PN) fertilization rate, high quality embryo formation rate, implantation rate, spontaneous abortion rate, and ectopic pregnancy rate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First IVF cycle;
  • With normal ovarian reserve(FSH < 10 mIU/mL; antral follicle count>5);
  • With normal uterine.
  • PCOS women according to Rotterdam criteria

Exclusion criteria

  • Pre-implantation genetic diagnosis cycles;
  • Oocyte donation or sperm donation cycles.

Treatment and study plan

GnRH-a

Drug

In experimental group, patients use long term GnRH-a; Patients' serum or follicle fluid will be collected if needed.

GnRH-anta

Drug

In control group, patients use GnRH-antagonist. Patients' serum or follicle fluid will be collected if needed.

Primary outcomes

  1. clinical pregnancy rate

    Time frame: 5 weeks after embryo transfer

    5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus

Secondary outcomes

  1. cumulative live birth rate

    Time frame: 2 years after oocyte retrivial

  2. Number of oocytes retrieved

    Time frame: 1 day at oocyte retrieved day

  3. 2 pronucleus (2PN) fertilization rate

    Time frame: 48 hours after oocyte retrieved day

    Number of 2PN/Matured oocytes

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Other

Registry information

Official study title

Follicular Long GnRH Agonist Versus Antagonist Protocol in PCOS Women Undergoing in Vitro Fertilization: a Prospective Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2022
Study completion
2024
First posted
Jul 14, 2015
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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