Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer

Phase 4

• Conditions: Infertility, Female; Clomiphene Citrate
• Interventions: Drug: Clomiphene Citrate protocol; Procedure: Procedure

• Registration Number: NCT03309436
• Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute

Brief Summary

Clomiphene citrate has been widely used for treatment of infertility for decades. Although its anti-estrogenic effects leads to low pregnancy rate, clomiphene citrate is still a first-line treatment for ovulation induction because of its simple usage, low prices, no injection and low risk of ovarian hyperstimulation syndrome. Clomiphene citrate shows high affinity with estrogen receptor, which inhibits endometrial proliferation, inevitably leads to a decline in endometrial receptivity, thus affecting the success rate of IVF.

In that case, use clomiphene citrate for ovulation induction is lost more than gained based on fresh embryo transfer. But recently, some researchers have proposed to extend the time from ovulation induction to embryo transfer, and the increased level of estradiol can replace clomiphene citrate to combine with the receptor, so that the uterine environment is more conducive to pregnancy. Therefore, use clomiphene citrate based on vitrification of embryo maybe a good way for treatment of infertility.

At present, using frozen embryo transplantation after ovulation induction by clomiphene citrate is a common treatment, but few research has mentioned the best time for embryo implantation. The investigators research is to find the most appropriate time for frozen embryo implantation after using clomiphene citrate for ovulation induction.

Detailed Description

This study receives patients from 2017 August to 2018 June who undergo ART treatment at Shanghai Jiai Genetics \& IVF Institute and taken either CC or GnRH antagonist protocol(control group) for ovulation induction.

The investigators will record every patients' age, BMI, serum E2, P, LH level, infertility factors and pregnancy outcomes, counted the implantation rate and clinical pregnancy rate, and then used SPSS Software x2 test for statistical analysis, the significance was set at p\<0.05.The investigators will also make a correlation analysis about the serum hormone level and pregnancy outcomes.

Study Timeline

• Study First Submitted: 2017-02-28
• Status Verified: 2017-08
• Study Start: 2017-08-07
• Study First Submitted QC: 2017-10-07
• Last Update Submitted: 2017-10-07
• Study First Posted: 2017-10-13
• Last Update Posted: 2017-10-13
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

Women 18-40 years of age who are scheduled for IVF or ICSI in our IVF institute while meeting the following criteria:

1. AMH ≥ 2;
2. Infertility factors: tubal factor, severe oligospermia, etc;
3. FET cycle;
4. Cleavage stage embryo transfer (Day 3).

Exclusion Criteria

1. BMI ≤ 18.4 or ≥ 25.0;
2. Have pregnancy complications;
3. Genital tract malformations, uterine cavity diseases, PCOS;
4. Endometriosis;
5. Genetic diseases, severe somatic diseases, mental disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use Clomiphene Citrate protocol	Clomiphene Citrate protocol	Ovulation induction: regular Clomiphene Citrate protocol. Start use rFSH or HMG from day 2/3 of the menstrual cycle, the initial dosage is determined by patients' age, BMI, antral follicle number, FSH, E2, AMH and past ovarian response, usually 150-225IU/d, until hCG injection. At the same time, take CC 100mg/d until hCG injection. The dosage of Gn will be adjust by serum E2, P, LH and the development of follicular.
Procedure	Procedure	Ovulation induction: regular GnRH antagonist protocol. Start use rFSH or HMG from day 2/3 of the menstrual cycle, the initial dosage is determined by patients' age, BMI, antral follicle number, FSH, E2, AMH and past ovarian response, usually 150-225IU/d, until hCG injection. When a dominant follicle diameter over 14mm or serum E2 over 350pg/ml, use GnRH-ant 0.25mg/d, until hCG injection. The dosage of Gn will be adjust by serum E2, P, LH and the development of follicular.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy	4 weeks after embryo transfer for the patient	Clinical pregnancy is defined as the presence of a gestational sac confirmed by transvaginal ultrasound examination.; Clinical pregnancy rate per treatment cycle will also be calculated based on ITT.

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy	12 weeks after embryo transfer for the patient	Ongoing pregnancy is defined as a viable intrauterine pregnancy after 12 weeks of embryo transfer. Ongoing pregnancy rate per treatment cycle will also be calculated on intend-to-treat(ITT) basis.
Implantation of transferred embryo	2 weeks after embryo transfer for the patient	Implantation rate per embryo transferred will also be calculated.

Trial Locations

Locations (1)

Shanghai Jiai Genetics & IVF Institute; 🇨🇳 Shanghai, China