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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Clinical Pregnancy Rate Ovulation Induction IVF

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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New protocol group

Use long term GnRH-a 3.75mg at day 2 of menstrual cycle. Around 30 days later, controlled ovarian hyperstimulation using gonadotropins is initiated.

Group Type EXPERIMENTAL

GnRH-a

Intervention Type DRUG

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

GnRH-antagonist

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.

Group Type ACTIVE_COMPARATOR

GnRH-anta

Intervention Type DRUG

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

Interventions

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GnRH-a

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

Intervention Type DRUG

GnRH-anta

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

Intervention Type DRUG

Eligibility Criteria

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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