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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02496754
Enrollment
1266
Registered
2015-07-14
Start date
2016-06-30
Completion date
2024-12-31
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Pregnancy Rate, IVF, Ovulation Induction

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.

Interventions

DRUGGnRH-a

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

DRUGGnRH-anta

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

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
22 Years to 38 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
clinical pregnancy rate5 weeks after embryo transfer5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus

Secondary

MeasureTime frameDescription
cumulative live birth rate2 years after oocyte retrivial
Number of oocytes retrieved1 day at oocyte retrieved day
2 pronucleus (2PN) fertilization rate48 hours after oocyte retrieved dayNumber of 2PN/Matured oocytes

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026