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

Zhengzhou University

Status: Completed

Conditions: IVF; Ovulation Induction; Clinical Pregnancy Rate

Treatments: Drug: GnRH-anta; Drug: GnRH-a

Study type: Interventional

Funder types: Other

Identifiers

NCT02496754

RMCZZU-New protocol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,266 patients

Sex: Female

Ages: 22 to 38 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,266 participants in 2 patient groups

New protocol group

Experimental group

Description:

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

Treatment:

Drug: GnRH-a

GnRH-antagonist

Active Comparator group

Description:

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.

Treatment:

Drug: GnRH-anta