The effectiveness of preventing premature luteinizing hormone surge by cetrorelix in the controlled ovarian stimulation by letrozole and gonadotropin

ISRCTN ISRCTN75248474
DOI https://doi.org/10.1186/ISRCTN75248474
Secondary identifying numbers N/A
Submission date
02/07/2006
Registration date
28/07/2006
Last edited
08/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hwang Jiann-Loung
Scientific

95 Wen-Chaung Road
Taipei
111
Taiwan

Email M001015@ms.skh.org.tw

Study information

Study designRandomized clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleThe effectiveness of preventing premature luteinizing hormone surge by cetrorelix in the controlled ovarian stimulation by letrozole and gonadotropin
Study acronymGnRH antagonist
Study objectivesInhibition of premature luteinizing hormone (LH) surge by cetrorelix in letrozole/follicle-stimulating hormone (FSH) may benefit pregnancy rate.
Ethics approval(s)Approved by the Institutional Review Board of Shin Kong Wu Wo-Su Memorial Hospital on 22/08/2004; reference number: 94E-168
Health condition(s) or problem(s) studiedCouples with unexplained or mild male factor infetility
InterventionLetrozole/FSH/cetrorelix versus Letrozole/FSH
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Letrozole, cetrorelix
Primary outcome measurePremature LH surge rate
Secondary outcome measures1. Pregnancy rate
2. Serum levels of inhibin B and leptin
Overall study start date01/01/2005
Completion date31/08/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants60
Total final enrolment61
Key inclusion criteria1. Patients of unexplained or mild male factor infertility
2. Body mass index (BMI) of 18-29 kg/m^2
Key exclusion criteria1. Anovulatory patients
2. Age ≥38 years of age
3. Day 3 FSH ≥10 mIu/ml
4. Previous low ovarian response by other controlled ovarian hyperstimulation (COH) protocol e.g. clomiphene citrate (CC)/FSH or FSH
Date of first enrolment01/01/2005
Date of final enrolment31/08/2006

Locations

Countries of recruitment

  • Taiwan

Study participating centre

95 Wen-Chaung Road
Taipei
111
Taiwan

Sponsor information

Shin Kong Hospital Research Department (Taiwan)
Hospital/treatment centre

95 Wen-Chaung Road
Taipei
111
Taiwan

ROR logo "ROR" https://ror.org/04x744g62

Funders

Funder type

Hospital/treatment centre

Shin Kong Wu Ho-Su Memorial Hospital Research Department

No information available

(SKH-8302-95-DR-21)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2008 08/01/2021 Yes No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.