Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Regionshospitalet Viborg, Skive.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Regionshospitalet Viborg, Skive
Information provided by:
Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier:
NCT00627406
First received: February 22, 2008
Last updated: March 5, 2008
Last verified: March 2008
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Purpose
The purpose of this study is to possibly further improve the clinical outcome and explore the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in GnRH antagonist IVF/ICSI cycles
| Condition | Intervention | Phase |
|---|---|---|
|
OHSS (Ovarian Hyperstimulation) |
Drug: Buserelin and Pregnyl Drug: Pregnyl |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomised Study to Evaluate the Effect of Triggering Ovulation With GnRHa (Buserelin) and Low Dose hCG (Pregnyl) as Compared to the Use of Conventional Doses of hCG (Pregnyl) |
Resource links provided by NLM:
Drug Information available for:
Chorionic Gonadotropin
Gonadorelin
Gonadorelin hydrochloride
Choriogonadotropin Alfa
U.S. FDA Resources
Further study details as provided by Regionshospitalet Viborg, Skive:
Primary Outcome Measures:
- Study groups A and B. Frequency of moderate to severe OHSS. Study groups C and D. Clinical pregnancy rate. [ Time Frame: Study groups A and B. From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Stimulation days, FSH consumption, MII oocytes aspirated, fertilization rate, transferable embryos per cycle, biochemical pregnancies, implantation rate, clinical pregnancy rate [ Time Frame: from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)
|
Drug: Buserelin and Pregnyl
Subcutaneous injection 0.5 mg and 1500 IU
|
|
Active Comparator: B
More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
|
Drug: Pregnyl
Subcutaneous injection 5000 IU
|
|
Experimental: C
14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)
|
Drug: Buserelin and Pregnyl
Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days
|
|
Active Comparator: D
14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)
|
Drug: Pregnyl
Subcutaneous injection 5000 IU
|
Eligibility| Ages Eligible for Study: | 20 Years to 39 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient complying with the conditions for IVF or ICSI treatment
- Female age over 20 years and under 40 years
- Normal regular cycle and patients with oligomenorrhea
- BMI > 18 and < 35
- each patient contributes with one cycle only
Exclusion Criteria:
- Significant disturbances in the woman (diabetes, epilepsy, liver/renal/heart disease, metabolic disorder)
- Patients with > 25 follicles on the day of triggering ovulation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627406
Contacts
| Contact: Peter S Humaidan, MD | +45 89 27 40 13 | peter.humaidan@sygehusviborg.dk |
| Contact: Alice T Mikkelsen, nurse | +45 89 27 40 85 |
Locations
| Denmark | |
| The Fertility Clinic, Regional Hospital of Skive | Recruiting |
| Skive, Denmark, 7800 | |
| Contact: Peter S Humaidan, MD +45 89 27 40 13 peter.humaidan@sygehusviborg.dk | |
| Contact: Alice T Mikkelsen, Nurse +45 89 27 40 85 | |
| Principal Investigator: Peter S Humaidan, MD | |
Sponsors and Collaborators
Regionshospitalet Viborg, Skive
Investigators
| Principal Investigator: | Peter S Humaidan, MD |
More Information
No publications provided
| Responsible Party: | Dr. Peter Humaidan |
| ClinicalTrials.gov Identifier: | NCT00627406 History of Changes |
| Other Study ID Numbers: | N-VN-2002-0046MCH |
| Study First Received: | February 22, 2008 |
| Last Updated: | March 5, 2008 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by Regionshospitalet Viborg, Skive:
|
GnRH antagonist GnRH agonist hCG OHSS |
In vitro fertilization ovulation induction Clinical pregnancy rate |
Additional relevant MeSH terms:
|
Ovarian Hyperstimulation Syndrome Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Chorionic Gonadotropin |
Buserelin Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Fertility Agents, Female Fertility Agents |
ClinicalTrials.gov processed this record on May 23, 2013