NCT03701490

Brief Summary

The objective of this proof of concept clinical trial is to evaluate the impact of two different progesterone treatments for endometrial preparation (25 mg/twice-a-day, subcutaneous injection, and 200 mg/three times a day, vaginal administration) on the clinical pregnancy rate in women undergoing frozen embryo transfer (FET) at blastocyst stage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2019

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2022

Completed
Last Updated

November 22, 2024

Status Verified

February 1, 2023

Enrollment Period

3.6 years

First QC Date

October 8, 2018

Last Update Submit

November 20, 2024

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    4-5 weeks after progesterone treatment start.

Secondary Outcomes (6)

  • Serum progesterone level

    19+/-2 days and 4-5 weeks after start progesterone treatment

  • Frequency of uterine contractions

    on the day of Embryo transfer (i.e. 5 days after start progesterone treatment)

  • Positive serum pregnancy (beta-hCG) test rate

    19+/-2 days after start progesterone treatment

  • Implantation rate

    4-5 weeks after start progesterone treatment.

  • Ongoing pregnancy rate

    9-11 weeks after start progesterone treatment.

  • +1 more secondary outcomes

Study Arms (2)

Prolutex

EXPERIMENTAL
Drug: Progesterone subcutaneous

Progeffik

EXPERIMENTAL
Drug: Progesterone Vaginal Product

Interventions

Progesterone subcutaneousDRUG

25 mg/twice a day.

Prolutex
Progesterone Vaginal ProductDRUG

200 mg three times a day.

Progeffik

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women attending the clinics to undergo a frozen blastocyst embryo transfer, having given written informed consent, with the following characteristics:
  • years of age for subjects undergoing ET with donated oocytes (both inclusive);
  • years of age for subjects undergoing ET with autologous oocytes (both inclusive);
  • BMI \<32 kg/m2;
  • Adequate endometrium preparation (Endometrial thickness \> 7 mm) and E2 levels ( \>100 pg/ml) on the day progesterone treatment is started;
  • P4 levels \<1.5 ng/ml on the day progesterone treatment is started;
  • Transfer of 1 or 2 frozen embryos at blastocyst stage
  • Transfer of frozen embryos of quality A and/or B according to Gardner criteria1;
  • Semen from ejaculation either from the partner or from a bank
  • ≤ 3 previous ET (frozen and fresh) with no pregnancy
  • Normal uterine cavity (i.e. no polyp or protruding sub-mucosal fibroid).

You may not qualify if:

  • Presence of functional follicles \> 10 mm of diameter on the day progesterone treatment is started;
  • Intramural uterine fibroids that distort the uterine cavity or polyps \>1 cm;
  • Stage III or IV endometriosis (endometriomas);
  • Hydrosalpinx;
  • Pregnancy or lactation
  • Malformations of the sexual organs incompatible with pregnancy;
  • Patients affected by pathologies associated with any contraindication of being pregnant;
  • Known allergy to progesterone preparations or their excipients;
  • Uncontrolled adrenal or thyroid dysfunction;
  • Undiagnosed vaginal haemorrhage;
  • History of, or current arterial disease;
  • Patients with hepatic impairment;
  • HIV, Hepatitis B Virus or Hepatitis C Virus seropositive;
  • Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
  • High grade cervical dysplasia;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Instituto Bernabeu

Alicante, 03016, Spain

Location

Instituto Bernabeu Madrid

Madrid, 28001, Spain

Location

Ginemed

Seville, 41010, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 10, 2018

Study Start

March 12, 2019

Primary Completion

September 28, 2022

Study Completion

December 3, 2022

Last Updated

November 22, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)