Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03309436|
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility, Female Clomiphene Citrate||Drug: Clomiphene Citrate protocol Procedure: Procedure||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer|
|Actual Study Start Date :||August 7, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||June 30, 2018|
Experimental: Use 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.
Drug: Clomiphene Citrate protocol
Take CC 100mg/d at the same time with Gn until hCG injection.
Other Name: CC
Active Comparator: 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.
When a dominant follicle diameter over 14mm or serum E2 over 350pg/ml, use GnRH-ant 0.25mg/d, until hCG injection.
Other Name: GnRH antagonist protocol
- Clinical pregnancy [ Time Frame: 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.
- Ongoing pregnancy [ Time Frame: 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 [ Time Frame: 2 weeks after embryo transfer for the patient ]Implantation rate per embryo transferred will also be calculated.
- Regression analysis 1 [ Time Frame: 12 weeks after embryo transfer for the patient ]Regression analysis about the pregnancy outcomes and patients' serum E2,P4,LH levels on the day of hCG injection
- Regression analysis 2 [ Time Frame: 12 weeks after embryo transfer for the patient ]Regression analysis about the pregnancy outcomes and patients' serum E2,P4,LH levels on the day of embryo transfer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309436
|Contact: YINING XU, MDfirstname.lastname@example.org|
|Shanghai Jiai Genetics & IVF Institute||Recruiting|
|Shanghai, China, 200011|
|Contact: XIAOXI SUN, MD 86-21-63456043 email@example.com|
|Study Chair:||XIAOXI SUN, MD||Shanghai Jiai Genetics & IVF Institute|