Clinical Trial Comparing Endometrial Transformation With Subcutaneous Progesterone Versus Intramuscular Progesterone

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567552
• Other study ID #: 1412-BCN-087-AB
• Secondary ID: 2015-000290-12
• Status: Completed
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2019
• Source: IVI Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The aim of this study is to compare predecidualization and endometrial receptivity as gene expression by using subcutaneous progesterone 25 mg/day versus intramuscular progesterone 50 mg/day in healthy women of childbearing age. Both, the two drugs and the doses administered in this clinical trial, are routine clinical practice.

A controlled ovarian stimulation will be previously performed and following routine clinical practice for 10-12 days at standard doses of subcutaneous FSH 150-225 IU/day, according to BMI and number of antral follicles. A GnRH antagonist shall be administered, being initiated according to donor's follicular growth from greater or equal14 mm diameter follicles. Final maturation shall be performed with a bolus of GnRH agonist when there exist at least 3 follicles greater or equal17 mm diameter, and therefore performing follicular puncture 36 hours after the bolus of agonist has been administered.

If the donor meets the inclusion criteria, she will be informed of the study and, if she agrees, she will sign the informed consent. Randomization shall be performed in 2 arms; arm 1 will be administered subcutaneous progesterone 25 mg/day (Prolutex; Angelini, Spain), and arm 2, intramuscular progesterone 50 mg/day (Prontogest IBSA, Italy). In each arm 12 donors (ITT population) will be included.

The randomization to a treatment group shall be performed the day the follicular puncture has been programmed. To that purpose, a randomized consecutive sampling will be used by means of assignment tables. The medication will be administered by a person not involved in the assessments and responsible for group assignment, data centralization and drug assignment.

At day 5 (5 days after follicular puncture):endometrial thickness measurement by means of transvaginal ultrasound and perform endometrial biopsy and take two samples: 1 sample to Anatomical Pathology and 1 sample to Endometrial Receptivity Array (ERA).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Reproductive Techniques, Assisted

Intervention

Drug:
• Subcutaneous progesterone
subcutaneous progesterone 25 mg/day
• Intramuscular progesterone
intramuscular progesterone 50 mg/day

Locations

Country	Name	City	State
Spain	IVI Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
IVI Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

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