Reproductive Techniques, Assisted Clinical Trial
Official title:
Randomized Clinical Trial Comparing Endometrial Transformation With Subcutaneous Progesterone (Prolutex) 25 mg/Day Versus Intramuscular Progesterone (Prontogest) 50 mg/Day
Verified date | February 2019 |
Source | IVI Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study the endometrial predecidualization by using subcutaneous progesterone 25 mg/day versus intramuscular progesterone 50 mg/day, to determine whether there are differences in the endometrial transformation and endometrial receptivity.
Status | Completed |
Enrollment | 24 |
Est. completion date | January 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 34 Years |
Eligibility |
Inclusion Criteria: - Female aged between 18 and 34 years - BMI between 18 and 28 kg/m2 - Endometrial thickness > 7 mm the day of progesterone treatment initiation (day of follicular puncture) - Follicular maturation with a single bolus of GnRH agonist - Egg donors who undergo a cycle of ovarian stimulation in the IVI Barcelona Centre - Egg donors selected in accordance with the requirements of Law 14/2006 of 26 May 2006 on Assisted Human Reproduction Techniques - Informed consent has been signed and dated Exclusion Criteria: - Known allergy to progesterone formulations or their excipients - Known allergy to estrogens - Known thrombophilias - Alcohol, drug or psychotropic medication dependence - Concurrent participation in another study - Concomitant medication that may interfere with the study medication and ovarian stimulation - Failure to comply with the requirements for egg donors in accordance with Law 14/2006 of 26 May 2006 on Assisted Human Reproduction Techniques |
Country | Name | City | State |
---|---|---|---|
Spain | IVI Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
IVI Barcelona |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Predecidual Transformation | Histologic dating of the endometrium at day 5: early secretory phase, media secretory phase or late secretory phase | 5 days | |
Primary | Decidualization of Stromal Cell | Rate of transformation of endometrial stromal fibroblasts into specialized secretory decidual cells (three categories: less than 25%, between 26% and 50%, and over 50%) | 5 days | |
Primary | Endometrial Maturation Using Noyes' Criteria | Endometrial dating of luteal phase days according to the Noyes criteria | 5 days | |
Primary | Endometrial Gene Expression | Gene expression profile of endometrial | 5 days | |
Primary | Endometrial Gene Expression Difference | Genes with a significantly high gene expression difference (adj-p-value < 0.05, Fold Change>3) | 5 days | |
Secondary | Endometrial Thickness | Endometrial thickness measurement by means of transvaginal ultrasound. | 5 days | |
Secondary | Blood Estradiol Level | Blood estradiol level on the day of follicular puncture | day 0 | |
Secondary | Blood Progesterone Level | Blood progesterone level on the day of follicular puncture | day 0 | |
Secondary | Blood LH Level | Blood Luteinizing hormone level on the day of follicular puncture | day 0 | |
Secondary | Blood Estradiol Level | Blood estradiol level 5 days after progesterone treatment | 5 days | |
Secondary | Blood Progesterone Level | Blood progesterone level 5 days after progesterone treatment | 5 days | |
Secondary | Blood LH Level | Blood Luteinizing hormone level 5 days after progesterone treatment | 5 days | |
Secondary | Number of Participants With Side Effects During the Study | Number of Participants with side effects during the study" | 5 days |
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