To Investigate the Cumulative Live Birth Rates Using GnRH Antagonist or Agonist Protocol for COS in ART Treatment (CLBR)

Peking University

Status: Unknown

Conditions: Sterility

Treatments: Procedure: GnRH-a long protocol; Procedure: GnRH-ant protocol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04026282

MS700623_0020

Details and patient eligibility

About

This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.

Full description

This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.

In this study, patients who are planning to undergo IVF/ICSI cycle aged ≤38 years old with normal ovarian reserve will be considered for enrollment. Approximately 888 patients will be enrolled at approximately 5 centers in China over a period of 10 months.

About 12-20 visits will be performed in this study for each patient. The CLBR with first live birth resulting from one initiated COS cycle will be compared between GnRH-a group and GnRH-ant group.

Enrollment: 888 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infertile women planning to undergo IVF/ICSI cycle using conventional GnRH agonist long protocol or GnRH antagonist protocol
• Age ≤ 38 years old
• Basal AFC 8~20
• Basal FSH≤10 IU/L
• Basal E 2 <200pmol/L
• Normal uterus and at least one side of the normal ovary
• Informed consent form signed
• Willing to follow the study protocol, and able to complete this study

Exclusion criteria

• Previous IVF/ICSI cycles >2
• Severe hydro-salpinx (Ultrasound shows hydro salpinx﹥2cm)
• Severe endometriosis (Grade III - IV)
• Polycystic ovarian syndrome (PCOS)
• History of recurrent miscarriages (>2 times of miscarriages)
• Plan to undergo ovarian stimulation for preimplantation genetic diagnosis or preimplantation genetic screening, oocyte donation, and social or medical freezing of oocytes
• Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study
• With pregnancy contraindications
• Alcoholism, drug abuse, drug addiction or patients with uncured sexually transmitted disease
• According to the judgment of the Investigator, any medical condition or any concomitant surgery/medications that would interfere with evaluation of study medications
• Simultaneous participation in another clinical study
• Plan to use urinary gonadotrophin during COS treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

888 participants in 2 patient groups

GnRH-ant protocol

Experimental group

Description:

Recombinant FSH (Gonal-f®) will be administrated as routinely practiced by investigators. FSH doses will be adjusted according to the clinical experiences of investigators.The GnRH-ant (Cetrotide®) will be initiated in a fixed protocol on stimulation days 5 or 6 per the investigator's ART protocol.

Treatment:

Procedure: GnRH-ant protocol

GnRH-a long protocol

Active Comparator group

Description:

The GnRH-a (Diphereline® or Decapetyl®) 0.1mg will be administered for about 14 to 20 days for down-regulation. Gonal-f® will be administrated as routinely practiced by investigators. GnRH-a types, GnRH-a and FSH doses will be adjusted according to the clinical experiences of investigators in each site.

Treatment:

Procedure: GnRH-a long protocol