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
Scientific
95 Wen-Chaung Road
Taipei
111
Taiwan
| M001015@ms.skh.org.tw |
Study information
| Study design | Randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | The effectiveness of preventing premature luteinizing hormone surge by cetrorelix in the controlled ovarian stimulation by letrozole and gonadotropin |
| Study acronym | GnRH antagonist |
| Study objectives | Inhibition 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) studied | Couples with unexplained or mild male factor infetility |
| Intervention | Letrozole/FSH/cetrorelix versus Letrozole/FSH |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Letrozole, cetrorelix |
| Primary outcome measure | Premature LH surge rate |
| Secondary outcome measures | 1. Pregnancy rate 2. Serum levels of inhibin B and leptin |
| Overall study start date | 01/01/2005 |
| Completion date | 31/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 60 |
| Total final enrolment | 61 |
| Key inclusion criteria | 1. Patients of unexplained or mild male factor infertility 2. Body mass index (BMI) of 18-29 kg/m^2 |
| Key exclusion criteria | 1. 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 enrolment | 01/01/2005 |
| Date of final enrolment | 31/08/2006 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
95 Wen-Chaung Road
Taipei
111
Taiwan
111
Taiwan
Sponsor information
Shin Kong Hospital Research Department (Taiwan)
Hospital/treatment centre
Hospital/treatment centre
95 Wen-Chaung Road
Taipei
111
Taiwan
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
