Phase 4 N=24 Randomized Single-blind Treatment

Clinical Trial Comparing Endometrial Transformation With Subcutaneous Progesterone Versus Intramuscular Progesterone

Reproductive Techniques, Assisted

Bottom Line

View on ClinicalTrials.gov: NCT02567552 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: Predecidual Transformation — 1; 2; 7; 8 participants — p=0.3395

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Subcutaneous progesterone (Drug); Intramuscular progesterone (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: IVI Barcelona
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Predecidual Transformation	1; 2; 7; 8; 4; 1	0.3395
PRIMARY Decidualization of Stromal Cell	3; 2; 3; 7; 6; 2	0.1523
PRIMARY Endometrial Maturation Using Noyes' Criteria	9.08; 7.64	0.1189
PRIMARY Endometrial Gene Expression	28; 28; 210; 210	—
PRIMARY Endometrial Gene Expression Difference	4; 4; 234; 234	—
SECONDARY Endometrial Thickness	8.46; 9.61	0.2042
SECONDARY Blood Estradiol Level	257.88; 246.45	0.8371
SECONDARY Blood Progesterone Level	3.16; 11.04	<0.0001 sig
SECONDARY Blood LH Level	1.30; 2.92	0.3107
SECONDARY Blood Estradiol Level	257.88; 246.45	0.8371
SECONDARY Blood Progesterone Level	3.16; 11.04	<0.0001 sig
SECONDARY Blood LH Level	1.30; 2.92	0.3107
SECONDARY Number of Participants With Side Effects During the Study	5; 4	0.5

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02567552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.