Tamoxifen and Clomiphene Citrate in Mild Stimulation IVF

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Infertility

Treatments: Drug: Clomiphene; Drug: Tamoxifen

Study type: Interventional

Funder types: Other

Identifiers

NCT02690870

20160220

Details and patient eligibility

About

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

Full description

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.

Enrollment: 210 estimated patients

Sex: Female

Ages: 37 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age between 37 and 42;
2. BMI≤23kg/m2;
3. ≤3 oocytes with a conventional stimulation protocol;
4. AFC<5 follicles or AMH<1.1 ng/ml on the day 1 to 5 of the menses;
5. Cause of Infertiity: tubal factor, male factor, diminished ovarian reserve.

Exclusion criteria

1. endormetrial polyp, endormetrial cancer,intrauterine adhesions,uterine fibroids that affects uterine cavity
2. Endometriosis, adenomyosis
3. The diameter of Hydrosalpinx >2cm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

tamoxifen

Experimental group

Description:

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.

Treatment:

Drug: Tamoxifen

clomiphene

Active Comparator group

Description:

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.

Treatment:

Drug: Clomiphene