Clinical trial NCT04026282: To Investigate the Cumulative Live Birth Rates Using GnRH Antagonist or Agonist Protocol for COS in ART Treatment
Official title: A Prospective, Randomized Controlled Study to Investigate the CLBRs of GnRH Antagonist Protocol Compared With the Standard GnRH Agonist Long Protocol for Controlled Ovarian Stimulation in Supposed Normal Ovarian Responders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sterility
Keywords: assisted reproductive technology
live birth
fertilization
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Merck Serono GmbH, Germany
name: Fountain Medical Development Co., Ltd.
name: Guangzhou KingMed Center for Clinical Lab.Co., Ltd
First posted: 2019-07-19
Enrollment: 888
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: When patients enter this study, they will be randomly assigned to GnRH-ant group or GnRH-a group at ratio1:1 by the randomization schedule generated by a computer program.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: the cumulative live birth rates
timeFrame: two years
Secondary outcomes:
measure: Number of oocytes retrieved
timeFrame: 24 hours after Oocytes pick up
measure: Good-quality embryo rate (The Istanbul Consensus29)
timeFrame: 24 hours after Oocytes pick up
measure: hCG positive rate
timeFrame: after 11 to 17 days of ET
measure: Implantation rate
timeFrame: 4 to 6 weeks after ET
measure: Clinical pregnancy rate
timeFrame: after 4 to 6 weeks of ET
measure: Ongoing pregnancy rate
timeFrame: after 12 weeks of ET
measure: Live birth rate
timeFrame: two years
measure: Cumulative clinical pregnancy rate
timeFrame: two years
measure: Miscarriage rate
timeFrame: after 12 weeks of ET
measure: Ectopic pregnancy rate
timeFrame: after 4 to 6 weeks of ET
measure: Cycle cancelled rate and reason
timeFrame: On ART cycle
measure: severity of OHSS
timeFrame: two weeks after Oocytes pick up
measure: Rate of OHSS
timeFrame: two weeks after Oocytes pick up
measure: Time to pregnancy
timeFrame: 4 to 6 weeks after ET
measure: Time to live birth
timeFrame: nine months after pregnancy
measure: the Safety
timeFrame: Two years after signature of informed consent
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Baoding
country: China
facility: The second hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: The third hospital of Zhengzhoui Medical University
state: Henan
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital
state: Zhejiang
Study officials:
affiliation: Peking University Third Hospital
name: Qiao Jie
role: PRINCIPAL_INVESTIGATOR
References: