NCT02690870

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2017

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

February 20, 2016

Last Update Submit

February 23, 2016

Conditions

Infertility

Keywords

tamoxifenclomiphenemild stimulationpoor ovarian responseclinical pregnancy rate

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    four weeks after embryo transfer

Secondary Outcomes (3)

  • 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

Study Arms (2)

tamoxifen

EXPERIMENTAL

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

clomiphene

ACTIVE COMPARATOR

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

Interventions

TamoxifenDRUG

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
tamoxifen
ClomipheneDRUG

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
clomiphene

Eligibility Criteria

Age37 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Boostanfar R, Jain JK, Mishell DR Jr, Paulson RJ. A prospective randomized trial comparing clomiphene citrate with tamoxifen citrate for ovulation induction. Fertil Steril. 2001 May;75(5):1024-6. doi: 10.1016/s0015-0282(01)01749-6.

    PMID: 11334921BACKGROUND

  • Revelli A, Casano S, Salvagno F, Delle Piane L. Milder is better? Advantages and disadvantages of "mild" ovarian stimulation for human in vitro fertilization. Reprod Biol Endocrinol. 2011 Feb 16;9:25. doi: 10.1186/1477-7827-9-25.

    PMID: 21324155BACKGROUND

  • Badawy A, Gibreal A. RETRACTED: Clomiphene citrate versus tamoxifen for ovulation induction in women with PCOS: a prospective randomized trial. Eur J Obstet Gynecol Reprod Biol. 2011 Nov;159(1):151-154. doi: 10.1016/j.ejogrb.2011.07.015. Epub 2011 Aug 9. No abstract available.

    PMID: 21831503BACKGROUND

  • Wang CW, Horng SG, Chen CK, Wang HS, Huang HY, Lee CL, Soong YK. Ovulation induction with tamoxifen and alternate-day gonadotrophin in patients with thin endometrium. Reprod Biomed Online. 2008 Jul;17(1):20-6. doi: 10.1016/s1472-6483(10)60288-x.

    PMID: 18616885BACKGROUND

  • Reynolds K, Khoury J, Sosnowski J, Thie J, Hofmann G. Comparison of the effect of tamoxifen on endometrial thickness in women with thin endometrium (<7mm) undergoing ovulation induction with clomiphene citrate. Fertil Steril. 2010 Apr;93(6):2091-3. doi: 10.1016/j.fertnstert.2009.08.038. Epub 2009 Sep 22.

    PMID: 19775686BACKGROUND

  • Brinton LA, Westhoff CL, Scoccia B, Lamb EJ, Trabert B, Niwa S, Moghissi KS. Fertility drugs and endometrial cancer risk: results from an extended follow-up of a large infertility cohort. Hum Reprod. 2013 Oct;28(10):2813-21. doi: 10.1093/humrep/det323. Epub 2013 Aug 13.

    PMID: 23943795BACKGROUND

  • Ozcan Cenksoy P, Ficicioglu C, Kizilkale O, Suhha Bostanci M, Bakacak M, Yesiladali M, Kaspar C. The comparision of effect of microdose GnRH-a flare-up, GnRH antagonist/aromatase inhibitor letrozole and GnRH antagonist/clomiphene citrate protocols on IVF outcomes in poor responder patients. Gynecol Endocrinol. 2014 Jul;30(7):485-9. doi: 10.3109/09513590.2014.893571. Epub 2014 Mar 5.

    PMID: 24592985BACKGROUND

  • Pourmatroud E, Zargar M, Nikbakht R, Moramazi F. A new look at tamoxifen: co-administration with letrozole in intrauterine insemination cycles. Arch Gynecol Obstet. 2013 Feb;287(2):383-7. doi: 10.1007/s00404-012-2556-3. Epub 2012 Sep 25.

    PMID: 23008110BACKGROUND

  • Mazzarino M, Biava M, de la Torre X, Fiacco I, Botre F. Characterization of the biotransformation pathways of clomiphene, tamoxifen and toremifene as assessed by LC-MS/(MS) following in vitro and excretion studies. Anal Bioanal Chem. 2013 Jun;405(16):5467-87. doi: 10.1007/s00216-013-6961-7. Epub 2013 Apr 23.

    PMID: 23604525BACKGROUND

  • Brown J, Farquhar C, Beck J, Boothroyd C, Hughes E. Clomiphene and anti-oestrogens for ovulation induction in PCOS. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD002249. doi: 10.1002/14651858.CD002249.pub4.

    PMID: 19821295BACKGROUND

  • Zakherah MS, Nasr A, El Saman AM, Shaaban OM, Shahin AY. Clomiphene citrate plus tamoxifen versus laparoscopic ovarian drilling in women with clomiphene-resistant polycystic ovary syndrome. Int J Gynaecol Obstet. 2010 Mar;108(3):240-3. doi: 10.1016/j.ijgo.2009.10.004. Epub 2009 Nov 26.

    PMID: 19944418BACKGROUND

  • Steiner AZ, Terplan M, Paulson RJ. Comparison of tamoxifen and clomiphene citrate for ovulation induction: a meta-analysis. Hum Reprod. 2005 Jun;20(6):1511-5. doi: 10.1093/humrep/deh840. Epub 2005 Apr 21.

    PMID: 15845599BACKGROUND

  • Wang HS, Wang TH, Soong YK. Cyclic changes in serum levels of insulin-like growth factor binding protein-1 in women treated with clomiphene citrate and tamoxifen. Gynecol Endocrinol. 2000 Aug;14(4):236-44. doi: 10.3109/09513590009167687.

    PMID: 11075292BACKGROUND

  • Mazzarino M, Bragano MC, de la Torre X, Molaioni F, Botre F. Relevance of the selective oestrogen receptor modulators tamoxifen, toremifene and clomiphene in doping field: endogenous steroids urinary profile after multiple oral doses. Steroids. 2011 Nov;76(12):1400-6. doi: 10.1016/j.steroids.2011.06.005. Epub 2011 Jun 30.

    PMID: 21745489BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

TamoxifenClomiphene

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Qingxue ZHANG

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    STUDY DIRECTOR

Central Study Contacts

Haiyan LIN

CONTACT

0018615913154456linhaiyan_818@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

February 20, 2016

First Posted

February 24, 2016

Study Start

January 1, 2017

Primary Completion

May 1, 2018

Study Completion

March 1, 2019

Last Updated

February 25, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Yes