Efficacy of indomethacin in in-vitro fertilisation treatment in the modified natural cycle
| ISRCTN | ISRCTN11805686 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11805686 |
| Protocol serial number | NL656 (NTR907) |
| Sponsor | University Medical Centre Groningen (UMCG) (The Netherlands) |
| Funder | University Medical Centre Groningen (UMCG) (The Netherlands) |
- Submission date
- 07/03/2007
- Registration date
- 07/03/2007
- Last edited
- 26/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M L Haadsma
Scientific
Scientific
University Medical Centre Groningen
Department of Obstetrics and Gynaecology
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 361 6161 |
|---|---|
| m.l.haadsma@og.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo controlled, parallel group, double blinded trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Efficacy of indomethacin in in-vitro fertilisation treatment in the modified natural cycle |
| Study objectives | Indomethacin is known to be a strong inhibitor of ovulation in the spontaneous menstrual cycle. Therefore we assume that the use of indomethacin prior to follicle aspiration in In-Vitro Fertilisation-treatment in the Modified Natural Cycle (IVF-MNC) significantly decreases the number of patients with one or more premature ovulations compared to placebo. |
| Ethics approval(s) | Approval received from the local medical ethics committee (Medisch Ethische Toetsingscommissie UMC Groningen) on the 24th June 2005 (ref: 2005/074). |
| Health condition(s) or problem(s) studied | In-vitro fertilisation-treatment in the modified natural cycle, IVF in the natural cycle |
| Intervention | Use of indomethacin (Indocid®) 50 mg versus placebo during IVF-treatment in the modified natural cycle. Dosage scheme: three times a day, starting on the day of ovulation triggering and ending on the morning of the follicle aspiration (total of seven capsules per cycle). |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Indomethacin (Indocid®) |
| Primary outcome measure(s) |
Number/percentage of patients per study group that have one or more ovulations prior to follicle aspiration. |
| Key secondary outcome measure(s) |
Number/percentage of patients per study group that achieve an on-going pregnancy (defined as an intact intra-uterine pregnancy at 12 weeks gestation) |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Indication for IVF or Intracytoplasmic Sperm Injection (ICSI) treatment 2. Age 18 up to 37 years 3. Ovulatory cycle of 26 to 35 days |
| Key exclusion criteria | 1. Prior IVF or ICSI treatment unless the last treatment was successful 2. Ovarian cysts disabling adequate sonographic assessment of the ovaries 3. Contraindications for indomethacin, such as asthma or prior gastro-intestinal ulcer |
| Date of first enrolment | 05/12/2005 |
| Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Groningen
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
