Clinical trial NCT03309436: Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer
Official title: Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility, Female
Clomiphene Citrate
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical pregnancy
timeFrame: 4 weeks after embryo transfer for the patient
Secondary outcomes:
measure: Ongoing pregnancy
timeFrame: 12 weeks after embryo transfer for the patient
measure: Implantation of transferred embryo
timeFrame: 2 weeks after embryo transfer for the patient
Other outcomes:
measure: Regression analysis 1
timeFrame: 12 weeks after embryo transfer for the patient
measure: Regression analysis 2
timeFrame: 12 weeks after embryo transfer for the patient
Locations:
city: Shanghai
country: China
facility: Shanghai Jiai Genetics & IVF Institute
Study officials:
affiliation: Shanghai Jiai Genetics & IVF Institute
name: XIAOXI SUN, MD
role: STUDY_CHAIR
References: