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Tamoxifen and Clomiphene Citrate in Mild Stimulation IVF

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ClinicalTrials.gov Identifier: NCT02690870
Recruitment Status : Unknown
Verified February 2016 by Haiyan Lin, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Recruitment status was:  Not yet recruiting
First Posted : February 24, 2016
Last Update Posted : February 25, 2016
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Haiyan Lin, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

Condition or disease Intervention/treatment Phase
Infertility Drug: Tamoxifen Drug: Clomiphene Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Tamoxifen and Clomiphene Citrate in Mild Stimulation IVF: a Prospective Cohort Study
Study Start Date : January 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 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
Patients in the tamoxifen group will take 20 mg of tamoxifen oral tablets daily from day 3 of the menses for 5 days.
Other Name: CAS RN:10540-29-1

Active Comparator: clomiphene
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 clomiphene group will take 100 mg of CC oral tablets daily from day 3 of the menses for 5 days.
Other Name: clomiphene citrate




Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: four weeks after embryo transfer ]

Secondary Outcome Measures :
  1. cycle cancellations for thin endrometrial thickness [ Time Frame: on the HCG day ]
  2. endrometrial pattern and thickness on the day of HCG administration [ Time Frame: on the HCG day ]
  3. the number of follicular diameter≥10mm and sexual hormone test on the HCG day [ Time Frame: on the HCG day ]


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Ages Eligible for Study:   37 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02690870


Contacts
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Contact: Haiyan LIN 0018615913154456 linhaiyan_818@163.com

Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sun Yat-sen University
Investigators
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Study Director: Qingxue ZHANG Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications:

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Responsible Party: Haiyan Lin, attending doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02690870    
Other Study ID Numbers: 20160220
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes
Keywords provided by Haiyan Lin, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
tamoxifen
clomiphene
mild stimulation
poor ovarian response
clinical pregnancy rate
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Tamoxifen
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents