Optimal Length of Progesterone Supplementation Before the Transfer of Cryopreserved (Frozen)-Thawed Day 3 Embryos in an Artificial Cycle With Exogenous Estrogen and Progesterone

NCT01940653 | Completed Phase 4 DMC

• 1 other identifier: PROFETA-3
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Cryopreserved-thawed embryos are often replaced in an artificial cycle, in which the endometrium is prepared by exogenous estrogen and progesterone with or without the use of GnRH agonist downregulation. The correct duration for exposure to progesterone is still not well established. To date, there are no prospective randomized trials available, comparing different durations of progesterone supplementation before the date of transfer, with regard to treatment outcome (Nawroth). In this trial, the investigators want to determine the optimal duration of progesterone supplementation: 3 or 5 days before embryo transfer.

Conditions

Progesterone Supplementation

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  7 weeks of pregnancy

Secondary Outcomes (1)

• live birth rate

  9 months after embryo transfer

Study Arms (2)

Progesterone

OTHER

Group A receives 5 days of micronized progesterone vaginally (Utrogestan® ((Utrogestan, Besins International). On the 5th (group A) of progesterone supplementation, the cryopreserved-thawed day 3 embryo is transferred.

Drug: Progesterone

progesterone 3 days

ACTIVE COMPARATOR

Group B receives 3 days of micronized progesterone vaginally. On the 3rd day of progesterone supplementation, the cryopreserved-thawed day 3 embryo is transferred.

Drug: Progesterone

Interventions

Progesterone DRUG

Procedures 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. All patients with an endometrium less than 7 mm on day 13 of estrogen stimulation, are excluded. Group A receives 5 days of micronized progesterone vaginally (Utrogestan® ((Utrogestan, Besins International), 3x200mg daily), group B receives 3 days of micronized progesterone vaginally. On the 5th (group A) or 3rd (group B) day of progesterone supplementation, the cryopreserved-thawed day 3 embryo is transferred.

Also known as: oestradiol valerate (Progynova®, Bayer-Schering Pharma AG, Berlin, Germany), progesterone (Utrogestan®, Besins International, France)

Progesterone; progesterone 3 days

Eligibility Criteria

• Age: Up to 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Artificial cycles, in which a frozen-thawed day 3 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)

UZ Brussel

Brussels, 1090, Belgium

Location

Related Publications (1)

• van de Vijver A, Polyzos NP, Van Landuyt L, Mackens S, Stoop D, Camus M, De Vos M, Tournaye H, Blockeel C. What is the optimal duration of progesterone administration before transferring a vitrified-warmed cleavage stage embryo? A randomized controlled trial. Hum Reprod. 2016 May;31(5):1097-104. doi: 10.1093/humrep/dew045. Epub 2016 Mar 22.

  PMID: 27005893 DERIVED

MeSH Terms

Interventions

Progesterone; Estradiol; Utrogestan

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; Estrenes; Estranes; Estradiol Congeners

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: September 9, 2013
• First Posted: September 12, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

BE (1)