Tamoxifen and Clomiphene Citrate in Mild Stimulation IVF

Study Overview
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Brief Summary
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The purpose of this prospective cohort study is to compare IVF outcome between tamoxifen and clomiphene citrate in mild stimulation.

Detailed Description
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The reported prevalence of poor ovarian responders amongst patients undergoing IVF-ET is 9%-24%, and morbidity must be higher nowadays. For these women, Mild stimulation has been an important ovulation induction protocol. Clomiphene citrate(CC) and tamoxifen(TMX) are commonly used in mild stimulation protocol. It's reported that CC has adverse effect on growth of endrometrium and results in thin endrometrium(≤7mm) which maybe affect pregnancy rate. However, TMX has estrogen-like effect on the endrometrium that may be helpful to increase endormetrial thickness. The reported results about comparing CC with TMX showed that they had similar ovulation rate. Prospective study is necessary to confirm whether TMX is superior to CC on the IVF outcome.

Official Title
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Comparison of Tamoxifen and Clomiphene Citrate in Mild Stimulation IVF: a Prospective Cohort Study

Conditions
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Infertility

Intervention / Treatment
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* Drug: Tamoxifen
* Drug: Clomiphene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 37 and 42; BMI≤23kg/m2; ≤3 oocytes with a conventional stimulation protocol; AFC<5 follicles or AMH<1.1 ng/ml on the day 1 to 5 of the menses; Cause of Infertiity: tubal factor, male factor, diminished ovarian reserve. Exclusion Criteria: endormetrial polyp, endormetrial cancer,intrauterine adhesions,uterine fibroids that affects uterine cavity Endometriosis, adenomyosis The diameter of Hydrosalpinx >2cm

Ages Eligible for Study
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Minimum Age: 37 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tamoxifen<br>All patients will have serum hormone examination and be monitored by transvaginal ultrasound for ovaries on the day 3 of the menses（D3）.Patients in the tamoxifen group will take 20 mg of tamoxifen oral tablets daily from D3 for 5 days.All patients will check serum E2 and be monitored by transvaginal ultrasound for the mean follicular diameter and endometrial thickness on the day 8 of the cycle. The investigators will add HMG and GnRH-ant according to follicular diameter,E2 and LH. Human chorionic gonadotropin(hCG) (5000-10000 IU IM) will be given when one follicle measured at least 18 mm is found. IVF or ICSI will be performed 34-36 h after hCG administration. All patients will receive luteal phase support with progesterone 60 mg im qd for 2 weeks. | Drug: Tamoxifen<br>* Patients in the tamoxifen group will take 20 mg of tamoxifen oral tablets daily from day 3 of the menses for 5 days.<br>* Other names: CAS RN：10540-29-1;|
| Active Comparator: clomiphene<br>All patients will have serum hormone examination and be monitored by transvaginal ultrasound for ovaries on the day 3 of the menses（D3）.Patients in clomiphene group will take 100 mg of CC oral tablets daily from D3 for 5 days.All patients will have sexual hormone determination and be monitored by transvaginal ultrasound for the mean follicular diameter and endometrial thickness on the day 8 of the cycle.The investigators will add HMG and GnRH-ant according to follicular diameter,E2 and LH. Human chorionic gonadotropin(hCG) (5000-10000 IU IM) will be given when one follicle measured at least 18 mm is found. IVF or ICSI will be performed 34-36 h after hCG injection. All patients will receive luteal phase support with progesterone 60 mg im qd for 2 weeks. | Drug: Clomiphene<br>* Patients in clomiphene group will take 100 mg of CC oral tablets daily from day 3 of the menses for 5 days.<br>* Other names: clomiphene citrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  | four weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cycle cancellations for thin endrometrial thickness |  | on the HCG day | 
| endrometrial pattern and thickness on the day of HCG administration |  | on the HCG day | 
| the number of follicular diameter≥10mm and sexual hormone test on the HCG day |  | on the HCG day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tamoxifen, clomiphene, mild stimulation, poor ovarian response, clinical pregnancy rate