Optimal Length of Progesterone Supplementation Before the Transfer of Cryopreserved(Frozen)-Thawed Embryos in an Artificial Cycle With Exogenous Estrogen and Progesterone.

NCT02032797 | Completed Phase 4

• 1 other identifier: PROFETA-5
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine whether 5 or 7 days of progesterone supplementation before transfer of a day 5 cryopreserved thawed embryos in an artificial cycle results in a significant higher pregnancy rate.

Conditions

Cryopreservation; Embryo Implantation; Progesteron

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  7 weeks of pregnancy

Secondary Outcomes (1)

• live birth rate

  40 weeks of pregnancy

Study Arms (2)

A: 7 days of progesterone

EXPERIMENTAL

Transvaginal ultrasound (US) and hormone analysis for FSH, LH, E2 and P on day 2 of the cycle will be performed. The artificial preparation of the endometrium consists of 7 days oestradiol valerate (Progynova®, Bayer-Schering Pharma AG, Berlin, Germany) 2 mg bid (bi-daily), followed by 6 days oestradiol valerate 2 mg tid (thrice daily). On day 13, the endometrium is measured. If endometrial thickness is more than 7 mm, patients are randomly assigned to group A or B. Group A receives 7 days of micronized progesterone vaginally (Utrogestan® ((Utrogestan, Besins International), 3x200mg daily), group B receives 5 days of micronized progesterone vaginally. On the 7th (group A) or 5th (group B) day of progesterone supplementation, the cryopreserved-thawed day 5 embryo is transferred.

Drug: Progesterone

B: 5 days of progesterone

PLACEBO COMPARATOR

Transvaginal ultrasound (US) and hormone analysis for FSH, LH, E2 and P on day 2 of the cycle will be performed. The artificial preparation of the endometrium consists of 7 days oestradiol valerate (Progynova®, Bayer-Schering Pharma AG, Berlin, Germany) 2 mg bid (bi-daily), followed by 6 days oestradiol valerate 2 mg tid (thrice daily). On day 13, the endometrium is measured. If endometrial thickness is more than 7 mm, patients are randomly assigned to group A or B. Group A receives 7 days of micronized progesterone vaginally (Utrogestan® ((Utrogestan, Besins International), 3x200mg daily), group B receives 5 days of micronized progesterone vaginally. On the 7th (group A) or 5th (group B) day of progesterone supplementation, the cryopreserved-thawed day 5 embryo is transferred.

Drug: Progesterone

Interventions

Progesterone DRUG

A: 7 days of progesterone; B: 5 days of progesterone

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Artificial cycles, in which a frozen-thawed day 5 embryo is replaced.
• Signed informed consent.
• Normal transvaginal ultrasound at screening, without evidence of clinically significant abnormality consistent with finding adequate for ART with respect to uterus and adnexa.
• Embryos must be frozen by vitrification technique (cfr supra).
• Single or dual embryo transfer.
• Recipients of oocyte donation cycles may be included.

You may not qualify if:

• Known allergic reactions to progesterone products.
• Intake of experimental drug within 30 days prior to study start.
• Contraindication for pregnancy.
• Embryos of women above 39 years of age at the time of embryo freezing.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Centre of Reproductive Medicine CRG

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 10, 2014
• Study Start: November 1, 2012
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

BE (1)