The efficacy of GnRH antagonists in cycles with mild ovarian hyperstimulation with recFSH in an intrauterine insemination program. A randomised placebo-controlled double-blinded investigator initiated study.
| ISRCTN | ISRCTN15295216 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15295216 |
| Secondary identifying numbers | NTR497 |
- Submission date
- 09/01/2006
- Registration date
- 09/01/2006
- Last edited
- 25/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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 B.J. Cohlen
Scientific
Scientific
Isala Clinics Zwolle, location Sophia
Department of Reproductive Medicine
Division of Obstetrics and Gynaecology
P.O. Box 10400
Zwolle
8000 GK
Netherlands
| Phone | +31 (0)38 4245000 |
|---|---|
| b.j.cohlen@isala.nl |
Study information
| Study design | Multicentre randomised double blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | IUI study IMP 26162 |
| Study objectives | We hypothesize that the use of a GnRH-antagonist in cycles with Mild Ovarian Hyperstimulation (MOH) combined with Intrauterine insemination (IUI) programs significantly improves live birth rates compared with MOH and a placebo. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Intrauterine Insemination (IUI), Infertility, Subfertility |
| Intervention | The research group of patients will consist of two arms: One group will receive ovarian stimulation with recFSH combined with placebo (the recFSH group). One group will receive recFSH combined with a GnRH-antagonist (the recFSH-anta group). Both ovarian stimulation protocols will be followed by intrauterine insemination. |
| Intervention type | Other |
| Primary outcome measure | Live birth rate per couple |
| Secondary outcome measures | 1. Total costs and cost-effectiveness 2. Ongoing (>12 weeks amenorrhoea) pregnancy rate per cycle commenced 3. Miscarriages (Preclinical miscarriage: spontaneous cessation of a biochemical pregnancy. Early miscarriage: any spontaneous abortion occurring after confirmation of clinical pregnancy and before completed 12 weeks of gestation. Late miscarriage: any spontaneous abortion occurring between completed 12 weeks of gestation and 16 completed weeks of gestation.) and ectopic pregnancies 4. Cumulative ongoing pregnancy rates per couple 5. Multiple births including the chorionicity 6. The occurrence of an LH surge or premature luteinization 7. Response of the ovaries to stimulation (number of follicles on day of Ovitrelle administration, speed of development, length of stimulation, quantities of medication used, etc.) |
| Overall study start date | 15/11/2005 |
| Completion date | 14/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Female |
| Target number of participants | 520 |
| Key inclusion criteria | Primary and secondary subfertile patients between 18 and 35 years of age with a diagnosis of unexplained or mild male infertility will be included. Definition of unexplained subfertility: 1. Normozoospermia using the guidelines of the WHO 2. Patent Fallopian tubes (both ovaries should be in situ) 3. Cycles varying between 24 and 35 days with an indication of ovulation 4. No abnormalities at laparoscopy and/or hysterosalpingography Information from the post-coital test when performed will only be used for a prognostic model and not as an exclusion criterion. |
| Key exclusion criteria | 1. Age of the woman <18 or >35 years 2. Duration of subfertility below 2 years 3. Manifest pathology of the Fallopian tubes 4. Severe forms of endometriosis (when laparoscopy has been performed: >AFS II) 5. An average total number of motile spermatozoa during semen analysis (performed twice in case of abnormal findings) below 10 million 6. Cycle disturbances (where otherwise ovulation induction would be used) 7. Previous IUI or IVF/ICSI treatment 8. If an initial ultrasound shows an image of a cyst that is larger than 25 mm treatment will be postponed for 1 month. Persistence of a cyst is a reason for exclusion. 9. Contraindications for recFSH (Gonal-F), rec-hCG (Ovitrelle) and Cetrotide |
| Date of first enrolment | 15/11/2005 |
| Date of final enrolment | 14/11/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Isala Clinics Zwolle, location Sophia
Zwolle
8000 GK
Netherlands
8000 GK
Netherlands
Sponsor information
Isala Clinics, Sophia (Isala Klinieken Locatie Sophia) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 10400
Zwolle
8000 GK
Netherlands
"ROR" |
https://ror.org/046a2wj10 |
|---|
Funders
Funder type
Research council
Reproductive Medicine Research and Education Foundation (Stichting Onderzoek en Onderwijs Voortplantingsgeneeskunde Zwolle [SOOVZ]) (Netherlands)
No information available
Serono Benelux B.V. (Netherlands)
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 |
