Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles

CRG UZ Brussel150 enrolled

Overview

To investigate the efficacy of dydrogesterone 30 mg compared to micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles, as confirmed by visualization of fetal heart activity by pelvic ultrasound assessment of ongoing pregnancy at 12 weeks of gestation.

A randomized controlled trial comparing dydrogesterone 30 mg versus micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles. Patients will undergo an embryo transfer in a hormone replacement therapy cycle using Progynova 2 mg three times daily until an endometrium thickness of at least 7 mm is reached. Afterwards two different luteal phase supplementation methods will be compared. The primary outcome of the study is ongoing pregnancy at 12 weeks of gestation. We will also investigate other prenatal and neonatal outcome factors as well as patients satisfaction and safety of dydrogesterone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Frozen Embryo Transfer Hormone Replacement Therapy Dydrogesterone Infertility, Female

Interventions

Dydrogesterone 10 MG Oral TabletDRUG

10 mg three times daily

Micronized progesteroneDRUG

2x 200 mg vaginal tablets two times daily

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≤40 years of age at the time of IVF/ICSI treatment * BMI ≥18 to ≤30 kg/m2 with a documented history of infertility * Have undergone COS as part of an ART treatment and have had an unsuccessful fresh embryo transfer in that cycle, OR, have undergone freeze all strategy * Scheduled to undergo FET with a standard exogenous/programmed hormonal replacement therapy (HRT) regimen * Have at least 1 blastocyst vitrified on the 5th or 6th day after oocyte retrieval * Elective single embryo (blastocyst) transfer (SET) * Normal ultrasound examination at enrollment (or if \<12 months old) * Signed patient authorization for use/disclosure of data. Exclusion Criteria: * Women with a history of recurrent miscarriage, defined as \>2 consecutive miscarriages (biochemical pregnancy losses are not included) * Absence of implantation (serum hCG = negative) after two consecutive cycles of IVF, ICSI or FET where the cumulative number of transferred embryos was \>4 cleavage-stage embryos and \>2 blastocysts * Presence of hydrosalpinx that is not surgically treated * Endometrial abnormalities on scanning during ovarian stimulation, such as endometrial polyp(s), sub mucosal fibroid(s), endometrial hyperplasia, endometrial fluid accumulation, or endometrial adhesions * Participating in another clinical study at the same time * Known allergic reactions to dydrogesterone or other progestogens products * Any contraindication or other condition that precludes use of dydrogesterone in a particular patient, in accordance with the precautions listed in the locally approved label * Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subjects in or to complete the study * History of prior chemotherapy * Contraindication for pregnancy * Transfer of \>1 embryo

Locations (1)

Brussels IVF

Brussels, Belgium

Outcomes

Primary Outcomes

Ongoing pregnancy

visualisation of a fetal heart activity via pelvic (vaginal/abdominal) ultrasound examination at 12 weeks of gestation.

Time frame: 12 weeks

Secondary Outcomes

Live birth rate

as the birth of a live newborn after 22 weeks of gestation

Time frame: 22-42 weeks

Time of delivery

time of delivery (gestational week) will be confirmed (by calculation from date of embryo transfer)

Time frame: follow-up time of 30 days after delivery

Incidence of Treatment-Emergent Adverse Events

Tolerability and safety will be asses during the whole study period. Adverse events will be considered as unexpected if the nature, seriousness, severity or outcome of the reaction(s) is not consistent with the reference information. The expectedness of adverse events for the medications used in this study is detailed in the reference safety information in the current summary of product characteristics (SmPCs) issued in the participating countries. All serieus suspected unexpected serious adverse drug reactions (SUSARs) will be subject to expedited reporting. The investigator is responsible for submitting reports of SUSARs to the appropriate national regulatory authorities within the required reporting period. The investigator is responsible for notifying the IECs/IRBs in writing of the SUSARs within the required reporting timelines. Copies of the notification will be maintained by the investigator in the study documentation files.

Time frame: follow-up time of 30 days after delivery

Patient reported outcome

Questionnaire (using the Treatment Satisfaction Questionnaire of Medication (TSQM)) and recording information on treatment tolerability and convenience

Time frame: day 12-18 of luteal phase supplementation (pregnancy test) and at 12 weeks gestation

Data from ClinicalTrials.gov

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