A Phase 4 interventional study of Tamoxifen and Clomiphene in Infertility, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Status unknown. Open to female participants aged 37 Years to 42 Years. Per ClinicalTrials.gov, last updated 2016-02-25.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 4, Interventional, and Treatment
The purpose of this prospective cohort study is to compare IVF outcome between tamoxifen and clomiphene citrate in mild stimulation.
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 210 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.
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Exclusion Criteria:
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
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
Patients in the tamoxifen group will take 20 mg of tamoxifen oral tablets daily from day 3 of the menses for 5 days.
Also known as: CAS RN：10540-29-1
Patients in clomiphene group will take 100 mg of CC oral tablets daily from day 3 of the menses for 5 days.
Also known as: clomiphene citrate
clinical pregnancy rate
Time frame: four weeks after embryo transfer
cycle cancellations for thin endrometrial thickness
Time frame: on the HCG day
endrometrial pattern and thickness on the day of HCG administration
Time frame: on the HCG day
the number of follicular diameter≥10mm and sexual hormone test on the HCG day
Time frame: on the HCG day
No study locations are listed for this record.
Plan to share: Yes — Yes
This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University