A Phase 4 interventional study of Buserelin and Pregnyl and Pregnyl in OHSS (Ovarian Hyperstimulation), sponsored by Regionshospitalet Viborg, Skive. Completed at 1 site in Denmark. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2013-11-27.
Sponsored by Regionshospitalet Viborg, Skive · Phase 4, Interventional, and Treatment
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
Regionshospitalet Viborg, Skive is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
More than 14 follicles with a diameter of \> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
Drug: Pregnyl
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
14 or less follicles with a diameter of \> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)
Drug: Pregnyl
Subcutaneous injection 0.5 mg and 1500 IU
Subcutaneous injection 5000 IU
Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days
Subcutaneous injection 5000 IU
Frequency of Moderate to Severe OHSS.
Time frame: From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test
Pregnancy Rate
Time frame: from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test
Recruitment period from jan. 2009 to dec. 2011. Participanting Clinics Fertility clinic Regional Hospital Skive, University Hostipal Odense, Regional Hospital Holbaek, Denmark.
| Milestone | A: >14 Follicles; GnRHa Trigger + 1500 hCG | B: >14 Follicles; hCG Trigger | C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 | D: <15 Follicles; hCG Trigger |
|---|---|---|---|---|
| Started | 60 | 58 | 125 | 141 |
| Completed | 60 | 58 | 125 | 141 |
| Not completed | 0 | 0 | 0 | 0 |
| participants | A: >14 Follicles; GnRHa Trigger + 1500 hCG | B: >14 Follicles; hCG Trigger | C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 | D: <15 Follicles; hCG Trigger |
|---|---|---|---|---|
| Frequency of Moderate to Severe OHSS. | 0 | 2 | 2 | 0 |
| participants | A: >14 Follicles; GnRHa Trigger + 1500 hCG | B: >14 Follicles; hCG Trigger | C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 | D: <15 Follicles; hCG Trigger |
|---|---|---|---|---|
| Pregnancy Rate | 17 | 15 | 37 | 36 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A: >14 Follicles; GnRHa Trigger + 1500 hCG | — | 0/60 (0%) | 0/60 (0%) |
| B: >14 Follicles; hCG Trigger | — | 0/58 (0%) | 0/58 (0%) |
| C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 | — | 0/125 (0%) | 0/125 (0%) |
| D: <15 Follicles; hCG Trigger | — | 0/141 (0%) | 0/141 (0%) |
| Age, Categorical(Participants) | A: >14 Follicles; GnRHa Trigger + 1500 hCG | B: >14 Follicles; hCG Trigger | C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 | D: <15 Follicles; hCG Trigger | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 60 | 58 | 125 | 141 | 384 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age Continuous(years) | A: >14 Follicles; GnRHa Trigger + 1500 hCG | B: >14 Follicles; hCG Trigger | C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 | D: <15 Follicles; hCG Trigger | Total |
|---|---|---|---|---|---|
| Mean | 28.5 ± 5.2 | 29.8 ± 3.8 | 30.8 ± 3.9 | 31.5 ± 3.7 | 30.2 ± 4.0 |
| Sex: Female, Male(Participants) | A: >14 Follicles; GnRHa Trigger + 1500 hCG | B: >14 Follicles; hCG Trigger | C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 | D: <15 Follicles; hCG Trigger | Total |
|---|---|---|---|---|---|
| Female | 60 | 58 | 125 | 141 | 384 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | A: >14 Follicles; GnRHa Trigger + 1500 hCG | B: >14 Follicles; hCG Trigger | C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 | D: <15 Follicles; hCG Trigger | Total |
|---|---|---|---|---|---|
| Denmark | 60 | 58 | 125 | 141 | 384 |
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Regionshospitalet Viborg, Skive