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

Not Applicable

Completed

• Conditions: Clinical Pregnancy Rate; Ovulation Induction; IVF
• Interventions: Drug: GnRH-a; Drug: GnRH-anta

• Registration Number: NCT02496754
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-14
• Study Start: 2016-06
• Primary Completion: 2022-12
• Study Completion: 2024-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-02
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1266

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New protocol group	GnRH-a	Use long term GnRH-a 3.75mg at day 2 of menstrual cycle. Around 30 days later, controlled ovarian hyperstimulation using gonadotropins is initiated.
GnRH-antagonist	GnRH-anta	In the GnRH antagonist protocol, Gn was injected from day 2-3 of the menstrual cycle and GnRH antagonist (Cetrotide; 0.25 mg) was added daily from day 6 of stimulation. When 2 dominant follicle ≥ 18 mm or three follicles ≥ 17 mm, recombinant human chorionic gonadotropin (hCG) was injected.

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	5 weeks after embryo transfer	5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus

Secondary Outcome Measures

Name	Time	Method
cumulative live birth rate	2 years after oocyte retrivial
Number of oocytes retrieved	1 day at oocyte retrieved day
2 pronucleus (2PN) fertilization rate	48 hours after oocyte retrieved day	Number of 2PN/Matured oocytes

Trial Locations

Locations (1)

Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China