Subcutaneous Progesterone Versus Vaginal Progesterone for Endometrial Preparation in Fresh Donated Oocytes Recipients
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|ClinicalTrials.gov Identifier: NCT02363127|
Recruitment Status : Completed
First Posted : February 13, 2015
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: subcutaneous progesterone Drug: vaginal progesterone||Phase 4|
Exploratory study with a control group treated according to our Service's usual therapeutic regimen for the transfer of embryos with donor oocytes.
The controlled ovarian stimulation protocol in oocyte donors is always calculated according to the standard protocol at the Bernabeu Institute. Endometrial preparation will be carried out following the standard protocol of the Bernabeu Institute as follows: the oestrogen will be administered transdermally and patients with maintained ovarian function undergo medical hypophysectomy with depot GnRH agonists administered in the mid-luteal phase of the previous cycle.
On the day of oocyte retrieval, the patient will be randomised: Group A will be administered subcutaneous progesterone 25 mg/day (Prolutex), and Group B will be administered vaginal progesterone in capsules 200 mg/3 times a day (Progeffik).
The embryo transfer will be performed on day 5 of the embryo culture (Day +5). A biochemical pregnancy test beta- hCG and the P4 analysis will be performed 14 days after oocyte retrieval.
All the cycles will be monitored according to the Department's standard criteria, using transvaginal ultrasound to assess embryonic development and endometrial thickness, as well as analytical controls.
The study will be blinded to the investigator. The evaluating professionals will not know if the subject has been administered vaginal progesterone or subcutaneous progesterone. The medication will be delivered by a person who does not participate in the evaluations and who is dedicated to group assignment, to data centralisation, and to delivering the medication.
The aim of this study is to determine if the ongoing pregnancy rate in patients undergoing a fresh embryo transfer cycle with donor oocytes is affected by the progesterone administration route.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Subcutaneous Progesterone (Prolutex) Versus Vaginal Progesterone Capsules (Progeffik) for Endometrial Preparation in Fresh Donated Oocytes Recipients: a Randomised, Prospective, Single-blind, Pilot Study|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||December 2016|
Drug: subcutaneous progesterone
subcutaneous progesterone 25 mg/day
Other Name: Protulex
Active Comparator: Progeffik
Drug: vaginal progesterone
vaginal progesterone in capsules 200 mg/3 times a day
Other Name: Progeffik
- ongoing pregnancy rate at 12 weeks gestation [ Time Frame: 12 weeks ]ongoing pregnancy rate at 12 weeks gestation using subcutaneous progesterone and using vaginal progesterone capsules
- progesterone level on the days of the transfer [ Time Frame: 5 days ]progesterone level on the days of the transfer
- progesterone level on biochemical pregnancy test beta-hCG [ Time Frame: 14 days ]progesterone level on biochemical pregnancy test beta-hCG
- endometrium thickness on the day of oocyte retrieval [ Time Frame: 0 day ]endometrium thickness on the day of oocyte retrieval
- endometrium thickness on the day of embryo transfer [ Time Frame: 5 days ]endometrium thickness on the day of embryo transfer
- endometrium morphology on the day of oocyte retrieval [ Time Frame: 0 day ]endometrium morphology (trilaminar pattern and echogenicity) on the day of oocyte retrieval
- endometrium morphology on the day of embryo transfer [ Time Frame: 5 days ]endometrium morphology (trilaminar pattern and echogenicity) on the day of embryo transfer
- implantation rate [ Time Frame: 4-5 weeks ]number of embryo sacs at 4-5 weeks (by ultrasound) versus number of embryos transferred
- positive biochemical pregnancy test beta- hCG rate [ Time Frame: 14 days ]positive biochemical pregnancy test beta- hCG rate at 14 days
- clinical pregnancy rate [ Time Frame: 4-5 weeks ]rate of patients with embryo any sac with a heartbeat (by ultrasound)
- miscarriage rate [ Time Frame: 10 weeks ]miscarriage rate in patients with positive biochemical pregnancy test beta- hCG rate on day +14
- occurrence of side effects [ Time Frame: day 5, day 14, 4-5 days, 10 weeks ]occurrence of side effects associated with progesterone
- comfort in relation to the progesterone administration route [ Time Frame: 10 weeks ]comfort in relation to the progesterone administration route
- number of uterine contractions per minute [ Time Frame: day 5 ]number of uterine contractions per minute on the day of embryo transfer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363127
|Alicante, Spain, 03016|
|Principal Investigator:||Joanquin Llacer, Ph||Instituto Bernabeu|