SHorter Treatment of Replacement Therapy for Frozen Embryo Transfer (FET)

NCT03930706 | Completed

• 1 other identifier: HRT1vs2week.2018
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Single-centre pilot study, randomized, controlled open-label trial with the aim to assess the clinical pregnancy rate and the early pregnancy loss rate between two different schemas for frozen embryo transfer cycles stimulated with HRT. Furthermore, the investigators would like to evaluate the predictivity of pregnancy and early miscarriage by looking at the endocrinological profile (estradiol and progesterone levels) within the endometrial preparation and the day of embryo transfer (ET).

Conditions

Infertility

Outcome Measures

Primary Outcomes (3)

• Clinical Pregnancy Rate

  The number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles or embryo transfer cycles. When clinical pregnancy rates are recorded, the denominator (initiated, aspirated or embryo transfer cycles) must be specified.

  2 years

• Live Birth Rate

  The number of deliveries that resulted in at least one live birth, expressed per 100 cycle attempts. In the case of assisted reproductive technologies (ART) interventions, they can be initiated cycles, insemination, aspiration cycles or embryo transfer cycles. When delivery rates are given, the denominator (initiated, inseminated, aspirated or embryo transfer cycles) must be specified.

  4 years

• Miscarriage rate

  The spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age, over the number of transferred embryos.

  2 years

Secondary Outcomes (3)

• positive hCG tests

  2 years

• biochemical pregnancy

  2 years

• early pregnancy loss

  2 years

Study Arms (2)

Group A

EXPERIMENTAL

Group A will include all the patient that will start with progesterone ((P), Utrogestan®) supplementation after 7 days of E2 (Progynova®) intake and that will perform the FET (after 13 days of E2 and 6 days of P).

Other: Longer administration of estradiol (Progynova®)

Group B

ACTIVE COMPARATOR

Group B will include the patients that will perform 14 days of E2 intake (Progynova®, 6 mg per day (2 mg every 8 hours) those patients will be asked to perform a supplementary blood test and ultrasound on day 14 of E2 intake, afterwards, they will start with P supplementation (Utrogestan®, 800 mg per day, 400 mg every 12 hours) from day 15 of E2 for 6 days and they will get their FET day 20 of the cycle (after 14 days of E2 and 6 days of P)

Other: Longer administration of estradiol (Progynova®)

Interventions

Longer administration of estradiol (Progynova®) OTHER

All women included will take exogenous hormone with daily administration of Estradiol Valerate (Progynova®), the standard dose used will be 6 mg/day (Cobo et al., n.d.). On day 7 of endometrial preparation patients will be examined with vaginal ultrasound and blood test, to evaluate the endometrial thickness and the hormones levels. In both arms the FET will take place after 6 days of Progesterone supplementation (600 mg per day, vaginal administration of Utrogestan®) According to embryo quality after warming, embryo transfer to the uterine cavity will be performed on day 5 of development under ultrasound guidance whenever possible. Following embryo transfer, luteal support will be continued with vaginally administered P (Utrogestan®). All patients 12 days after the FET will undergo the pregnancy test (blood test to evaluate hCG).

Also known as: comparing 7 vs 14 days of administration of estradiol (Progynova®) for artificially prepared endometrium in frozen embryo transfer

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

* Women aged ≥18 and \< 40 years * Unexplained infertility * Normal uterine cavity * IVF/ICSI * IVF cycle with GnRH agonist or antagonist * Single day 5 blastocyst transfer * Top quality embryo (at least Bl 3BA) at the moment of ET * Signed informed consent * Participants can be included only once in the trial * Informed consent documents signed prior to screening evalua-tions.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Related Publications (1)

• Racca A, Santos-Ribeiro S, Drakopoulos P, De Coppel J, Van Landuyt L, Tournaye H, Blockeel C. Clinical pregnancy rate for frozen embryo transfer with HRT: a randomized controlled pilot study comparing 1 week versus 2 weeks of oestradiol priming. Reprod Biol Endocrinol. 2023 Jul 7;21(1):62. doi: 10.1186/s12958-023-01111-8.

  PMID: 37420186 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Blockeel

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 29, 2019
• Study Start: October 1, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

BE (1)