Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer

Infertility, Female Clinical Trial

Official title:

Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03309436
• Other study ID #: JIAI E2017-11
• Status: Recruiting
• Phase: Phase 4
• First received: February 28, 2017
• Last updated: October 7, 2017
• Start date: August 7, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: August 2017
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: YINING XU, MD
• Phone: 86-13564548586
• Email: 10301010067[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clomiphene Citrate
• Infertility
• Infertility, Female

Intervention

Drug:
• Clomiphene Citrate protocol
Take CC 100mg/d at the same time with Gn until hCG injection.

Procedure:
• Procedure
When a dominant follicle diameter over 14mm or serum E2 over 350pg/ml, use GnRH-ant 0.25mg/d, until hCG injection.

Locations

Country	Name	City	State
China	Shanghai Jiai Genetics & IVF Institute	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Regression analysis 1	Regression analysis about the pregnancy outcomes and patients' serum E2,P4,LH levels on the day of hCG injection	12 weeks after embryo transfer for the patient
Other	Regression analysis 2	Regression analysis about the pregnancy outcomes and patients' serum E2,P4,LH levels on the day of embryo transfer	12 weeks after embryo transfer for the patient
Primary	Clinical pregnancy	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.	4 weeks after embryo transfer for the patient
Secondary	Ongoing pregnancy	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.	12 weeks after embryo transfer for the patient
Secondary	Implantation of transferred embryo	Implantation rate per embryo transferred will also be calculated.	2 weeks after embryo transfer for the patient