Status
Unknown
Phase
Not applicable
Enrollment
888
Locations
4
Results
Not posted
Publications
0
Study 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.
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.
Interventions
PROCEDURE
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.
PROCEDURE
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.
Timeline
First posted
Jul 19, 2019
Study start
Dec 27, 2018
Primary completion
Oct 30, 2021
Study completion
Jul 31, 2022
Results posted
Not reported
Registry updated
Nov 8, 2019
Outcomes
the cumulative live birth rates
Time frame · two years
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.
Number of oocytes retrieved
Time frame · 24 hours after Oocytes pick up
recorded Number of oocytes retrieved on DOPU
Good-quality embryo rate (The Istanbul Consensus29)
Time frame · 24 hours after Oocytes pick up
Total the number of good quality embryos divided by Total the number of embryos
hCG positive rate
Time frame · after 11 to 17 days of ET
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
Implantation rate
Time frame · 4 to 6 weeks after ET
the number of gestational sacs observed divided by the number of embryos transferred
Clinical pregnancy rate
Time frame · after 4 to 6 weeks of ET
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.
Ongoing pregnancy rate
Time frame · after 12 weeks of ET
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).
Live birth rate
Time frame · two years
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.
Cumulative clinical pregnancy rate
Time frame · two years
Numerator is the No. of women got their first clinical pregnancy, the Denominator is the No. of women who attempt the ovarian stimulation.
Miscarriage rate
Time frame · after 12 weeks of ET
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 .
Ectopic pregnancy rate
Time frame · after 4 to 6 weeks of ET
the number of .extrauterine pregnancy divided by the number of Clinical pregnancy .
Eligibility
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
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Peking University Third Hospital
Beijing, Beijing Municipality, China
The second hospital of Hebei Medical University
Baoding, Hebei, China
The third hospital of Zhengzhoui Medical University
Zhengzhou, Henan, China
Jiangsu Provincial Hospital
Nanjing, Zhejiang, China
Publications
No PMID-linked publications were present in this registry snapshot.
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