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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
888
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.
The GnRH-a (Diphereline® or Decapetyl®) 0.1mg will be administered for about14 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.
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe second hospital of Hebei Medical University
Baoding, Hebei, China
RECRUITINGThe third hospital of Zhengzhoui Medical University
Zhengzhou, Henan, China
RECRUITINGthe cumulative live birth rates
To investigate the cumulative live birth rates in infertile women ≤ 38 years old with normal ovarian from one initiated COS cycle. reserve using GnRH antagonist or agonist protocol for COS in ART treatment Numerator is the No. of women got their first live birth, the Denominator is the No. of women who attempt the ovarian stimulation. There will be two ways to calculate the CLBR: * The conservative estimate of the cumulative live birth rate, which is based on the assumption that none of the women who do not return for a subsequent embryo transfer would have had a live birth. * The optimal estimate of the cumulative live birth rate, which is based on the assumption that women who do not return for a subsequent embryo transfer would have had the same live birth rates as those who do return.
Time frame: two years
Number of oocytes retrieved
recorded Number of oocytes retrieved on DOPU
Time frame: 24 hours after Oocytes pick up
Good-quality embryo rate (The Istanbul Consensus29)
Total the number of good quality embryos divided by Total the number of embryos
Time frame: 24 hours after Oocytes pick up
hCG positive rate
Numerator is the No.of β-hCG blood test which is positive results, he Denominator is the No. of β-hCG blood test. HCG test is Serum β-hCG test after 11 to 17
Time frame: after 11 to 17 days of ET
Implantation rate
the number of gestational sacs observed divided by the number of embryos transferred
Time frame: 4 to 6 weeks after ET
Clinical pregnancy rate
the number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, or embryo transfer cycles. Note: When clinical pregnancy rates are given, the denominator (initiated, aspirated, or embryo transfer cycles) must be specified.
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Jiangsu Provincial Hospital
Nanjing, Zhejiang, China
RECRUITINGTime frame: after 4 to 6 weeks of ET
Ongoing pregnancy rate
the number of . Ongoing pregnancy divided by the number of Clinical pregnancy . Ongoing pregnancy is intrauterine pregnancy continued for 12 gestational weeks (detection of presence of gestational sac with fetal heartbeat by transvaginal ultrasound examination in week 12).
Time frame: after 12 weeks of ET
Live birth rate
Numerator is the No. of women got live birth resulting from fresh cycle (multiple births considered as one live birth), the Denominator is the No. of women who attempt the ovarian stimulation.
Time frame: two years
Cumulative clinical pregnancy rate
Numerator is the No. of women got their first clinical pregnancy, the Denominator is the No. of women who attempt the ovarian stimulation.
Time frame: two years
Miscarriage rate
the number of Miscarriage which is the natural death of an embryo or fetus before it is able to survive independently divided by the number of Clinical pregnancy .
Time frame: after 12 weeks of ET
Ectopic pregnancy rate
the number of .extrauterine pregnancy divided by the number of Clinical pregnancy .
Time frame: after 4 to 6 weeks of ET
Cycle cancelled rate and reason
Cancelled cycle is an ART cycle in which ovarian stimulation or monitoring has been carried out with the intention to treat, but which did not proceed to follicular aspiration or, in the case of a thawed embryo, to embryo transfer. Cycle cancelled rate is the number of Cancelled cycle divided by the number of embryos transferred.
Time frame: On ART cycle
severity of OHSS
Assessed the severity of OHSS.
Time frame: two weeks after Oocytes pick up
Rate of OHSS
the number of OHSS divided by the number of ovum pick up. Assessed the severity of OHSS.
Time frame: two weeks after Oocytes pick up
Time to pregnancy
time from Gn Initiation to the first clinical pregnancy.
Time frame: 4 to 6 weeks after ET
Time to live birth
time from Gn Initiation to the first live birth
Time frame: nine months after pregnancy
the Safety
Data on AEs will be collected at scheduled and unscheduled visits, based on information spontaneously provided by the subject and/or through questioning of the subject.
Time frame: Two years after signature of informed consent