NCT02775877

Brief Summary

The purpose of this study is to study the effects of letrozole and sequential clomiphene in ovulation and pregnancy in PCOS patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

December 29, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

3.1 years

First QC Date

December 29, 2015

Last Update Submit

June 21, 2017

Conditions

Female Infertility Due to Nonimplantation of Ovum

Keywords

PCOSletrozoleclomiphene

Outcome Measures

Primary Outcomes (1)

  • live birth rate

    The event that a FETUS is born alive with heartbeats or RESPIRATION

    3 years

Secondary Outcomes (4)

  • clinical pregnancy rate

    3 years

  • multiple pregnancies

    3 years

  • miscarriage

    3 years

  • mature follic

    1 month

Study Arms (2)

letrozole and clomiphene

EXPERIMENTAL

Letrozole 5 mg tablet orally from 3-7 day of once a day menstrual cycle and clomiphene100 mg tablet orally once a day from 11-15 day of menstrual cycle.

Drug: LetrozoleDrug: clomiphene

Letrozole and human menopausal gonadotropin (HMG)

ACTIVE COMPARATOR

Letrozole 5 mg tablet orally from 3-7 day of once a day menstrual cycle and HMG 75u once a day by intramuscular injection from 11-15day of menstrual cycle

Drug: LetrozoleDrug: HMG

Interventions

LetrozoleDRUG
Letrozole and human menopausal gonadotropin (HMG)letrozole and clomiphene
clomipheneDRUG
letrozole and clomiphene
HMGDRUG
Letrozole and human menopausal gonadotropin (HMG)

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women with PCOS

You may not qualify if:

  • Women more than 38 years or less than 20 years
  • With infectious diseases or endocrine diseases
  • Who refuse to participate in the experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Navy General Hospital.

Beijing, Beijing Municipality, 100048, China

RECRUITING

Related Publications (4)

  • Kamath MS, George K. Letrozole or clomiphene citrate as first line for anovulatory infertility: a debate. Reprod Biol Endocrinol. 2011 Jun 21;9:86. doi: 10.1186/1477-7827-9-86.

    PMID: 21693034BACKGROUND

  • Legro RS, Kunselman AR, Brzyski RG, Casson PR, Diamond MP, Schlaff WD, Christman GM, Coutifaris C, Taylor HS, Eisenberg E, Santoro N, Zhang H; NICHD Reproductive Medicine Network. The Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial: rationale and design of a double-blind randomized trial of clomiphene citrate and letrozole for the treatment of infertility in women with polycystic ovary syndrome. Contemp Clin Trials. 2012 May;33(3):470-81. doi: 10.1016/j.cct.2011.12.005. Epub 2012 Jan 13.

    PMID: 22265923BACKGROUND

  • Hajishafiha M, Dehghan M, Kiarang N, Sadegh-Asadi N, Shayegh SN, Ghasemi-Rad M. Combined letrozole and clomiphene versus letrozole and clomiphene alone in infertile patients with polycystic ovary syndrome. Drug Des Devel Ther. 2013 Dec 3;7:1427-31. doi: 10.2147/DDDT.S50972. eCollection 2013.

    PMID: 24348019RESULT

  • Legro RS, Zhang H; Eunice Kennedy Shriver NICHD Reproductive Medicine Network. Letrozole or clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med. 2014 Oct 9;371(15):1463-4. doi: 10.1056/NEJMc1409550. No abstract available.

    PMID: 25295506RESULT

MeSH Terms

Interventions

LetrozoleClomiphene

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Aiming Wang, Dr

    Navy General Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li He

CONTACT

17710379833qiufengyi0505@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Obstetrics and Gynecology, Navy General Hospital, Beijing

Study Record Dates

First Submitted

December 29, 2015

First Posted

May 18, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2019

Study Completion

January 1, 2020

Last Updated

June 23, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Locations

CN(1)