Study to compare the endometrial transformation with 25 mg / day of subcutaneous progesterone(Prolutex) versus 50 mg / day intramuscular progesterone (Prontogest)

Randomized Clinical Trial comparing the endometrial transformation with 25 mg/day of subcutaneous progesterone (Prolutex) versus 50 mg/day intramuscular progesterone (Prontogest)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000290-12-ES

Enrollment

Unknown

Registered

2015-04-14

Start date

2015-06-26

Completion date

Unknown

Last updated

2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility. Assisted Reproductive Techniques.

Interventions

Trade Name: Prolutex 25 mg solución inyectable Pharmaceutical Form: Solution for injection INN or Proposed INN: PROGESTERONE CAS Number: 57-83-0 Current Sponsor code: G03DA04 Other descriptive name: p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Female age between 18 and 34 years (inclusive) BMI between 18 and 28 kg / m2 (inclusive) Endometrial thickness greater 7 mm on day of beginning progesterone treatment (day of follicular puncture) Follicular maturation with bolus GnRH agonist Egg donors who make a cycle of ovarian stimulation in the IVI Barcelona Centre Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known allergy to progesterone preparations or its excipients Known allergy to estrogens Known thrombophilia Dependence on alcohol, drugs or psychotropic Concurrent participation in another study Concomitant medications that may interfere with the study medication and ovarian stimulation Not complying the requirements for egg donors according to Law 14/2006 of 26 May 2006 on Assisted Human Reproduction Techniques

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Plasmatic levels of progesterone Plasmatic levels of estradiol Plasmatic levels of LH;Timepoint(s) of evaluation of this end point: Plasmatic levels of hormones: before starting treatment with progesterone (Day -2), Day of the programming of the follicular puncture, Day of the follicular puncture and the 5 th Day of the progesterone administration / ending of the study	—

Primary

Measure	Time frame
Main Objective: To study the predecidualización endometrial (ie, measuring the effects of progesterone in the endometrial glands and stroma in the luteal phase) and endometrial receptivity on Day 5 as gene expression, following daily administration of 25 mg / day of subcutaneous progesterone and 50 mg / day intramuscular progesterone, both for 5 days, to see if there are differences in the use of both progesterone.;Secondary Objective: To study plasma levels of progesterone, estradiol and LH on different days (Day programming follicular puncture Day follicular puncture and Day 5 of administration of progesterone / end of the study).;Primary end point(s): Endometrium predecidulacion: endometrial thickness (mm), endometrial transformation after treatment according to criteria of Noyes at al., endometrial receptivity on day 5 as gene expression profile (ERA);Timepoint(s) of evaluation of this end point: day 5	—

Measure

Time frame

Main Objective: To study the predecidualización endometrial (ie, measuring the effects of progesterone in the endometrial glands and stroma in the luteal phase) and endometrial receptivity on Day 5 as gene expression, following daily administration of 25 mg / day of subcutaneous progesterone and 50 mg / day intramuscular progesterone, both for 5 days, to see if there are differences in the use of both progesterone.;Secondary Objective: To study plasma levels of progesterone, estradiol and LH on different days (Day programming follicular puncture Day follicular puncture and Day 5 of administration of progesterone / end of the study).;Primary end point(s): Endometrium predecidulacion: endometrial thickness (mm), endometrial transformation after treatment according to criteria of Noyes at al., endometrial receptivity on day 5 as gene expression profile (ERA);Timepoint(s) of evaluation of this end point: day 5

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Countries

Spain

Contacts

Public ContactMedicina Reproductiva

Clínica IVI Barcelona

agustin.ballesteros@ivi.es0034932 063 000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026