Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| The Fertility Clinic, Skive Regional Hospital, Denmark | UNKNOWN |
| Aarhus University Hospital | OTHER |
| University of Southern Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this randomized single center study is to explore the most optimal dose of GnRHa used for triggering of final oocyte maturation in IVF. The study group will consist of oocyte donors who have GnRHa trigger as a standard trigger concept.
Hypothesis: In an Asian oocyte donor population, the use of 0.2 mg, 0.3mg or 0.4 mg of GnRHa will lead to the retrieval of comparable numbers of mature oocytes (MII) and good quality embryos. Moreover, the reproductive outcome in the recipients will be similar regardless of the dose of GnRHa used for trigger.
Methods
A randomized controlled single center study. All oocyte donors, fulfilling the inclusion criteria, will be eligible for inclusion after randomization.
Stimulation, monitoring, oocyte pick-up in donors and embryo transfer in recipients On day two of the cycle, - i.e. prior to commencing stimulation with long acting FSH (Elonva) - donors will be randomized to one of three groups, using different doses of GnRHa (Triptorelin) for trigger. Stimulation will be performed according to the standard stimulation protocol of the clinic, using Elonva followed by co-treatment with a GnRH antagonist from day 5 of stimulation . The dose of Elonva used for stimulation will be either 100 or 150 µg according to the weight of the patient. The first transvaginal ultrasound scan (TVUS) will be performed after seven or eight days after the Elonva depot injection. As soon as two follicles have reached a size of ≥ 17mm, triggering of final oocyte maturation will be performed with one single bolus of Triptorelin, 0.2 mg, 0.3mg or 0.4 mg. The timing of the trigger will be 6 AM for all groups and the oocyte pick-up (OPU) will be performed after 34 hours, according to the usual practice of the clinic. Importantly, each patient will be asked to check the presence of an LH surge via a urine LH detection kit at 4 hours after the trigger bolus has been administered. Embryo transfer will be performed on day two in all recipients.
Study group I Stimulation according to the abovementioned and ovulation trigger with 0.2mg Triptorelin. All other procedures will be performed according to the practice of the clinic.
Study group II Stimulation according to the abovementioned and ovulation trigger with 0.3mg Triptorelin. All other procedures will be performed according to the practice of the clinic.
Study group III Stimulation according to the abovementioned and ovulation trigger with 0.4mg Triptorelin. All other procedures will be performed according to the practice of the clinic.
Randomization Randomization will be performed using sealed envelopes developed via a computer generated list with blocks of twelve. The randomization will be performed on day two of the cycle. Doctors will be blinded to the randomization, but not patients and nurses.
Follicular fluid (FF) collection FF from the first punctured follicle on each side will be collected and cryo-preserved at -20 degrees for subsequent analysis of steroids.
Granulosa cell gene-expression analysis Cumulus and mural granulosa cells will be preserved and snap-frozen from a sub-group of 10 patients in each group. The primary subsequent analysis will focus on possible differences in LHR gene expression according to GnRHa trigger dose.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.2mg Triptorelin | Active Comparator | Ovulation trigger with 0.2mg Triptorelin in one subcutaneous injection. |
|
| 0.3mg Triptorelin | Active Comparator | Ovulation trigger with 0.3mg Triptorelin in one subcutaneous injection. |
|
| Active Comparator: 0.4mg Triptorelin | Active Comparator | Ovulation trigger with 0.4mg Triptorelin in one subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin | Drug | Triptorelin is given by s.c injection for ovulation triggering. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of mature oocytes | 30 minutes after oocyte retrieval completed |
| Measure | Description | Time Frame |
|---|---|---|
| Day of bleeding after oocyte pick-up | in 2 weeks after oocyte pick-up | |
| Clinical pregnancy | 5 weeks after oocyte pick-up |
Not provided
Inclusion Criteria:
Oocyte donors who meet the following criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tuong M Ho, MD | CGRH, School of Medicine, Vietnam National University HCMC, Vietnam | Principal Investigator |
| Lan TN Vuong, MD | Department of Obstetrics and Gynecology, University of Medicine and Pharmacy HCMC, Ho Chi Minh City, Vietnam | Principal Investigator |
| Peter Humaidan, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| My Duc Hospital, IVFMD | Ho Chi Minh City | Ho Chi Minh | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26523330 | Derived | Vuong TN, Ho MT, Ha TD, Phung HT, Huynh GB, Humaidan P. Gonadotropin-releasing hormone agonist trigger in oocyte donors co-treated with a gonadotropin-releasing hormone antagonist: a dose-finding study. Fertil Steril. 2016 Feb;105(2):356-63. doi: 10.1016/j.fertnstert.2015.10.014. Epub 2015 Oct 31. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| D011208 | Powders |
| D012997 | Solvents |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |