Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles

NCT03619707 | Completed Phase 4

• 1 other identifier: AmericanUBMC-CWET
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

In IVF/ICSI cycles, the progesterone levels induced by ovarian stimulation are low, therefore the luteal phase is supported by progesterone. The use of progestogens in IVF is associated with an improvement in the live birth rate Standard protocol for luteal phase support has not yet been established. Currently vaginal progesterone is widely used, since the classic oral progesterone seems to result in a low bioavailability and a lower pregnancy rate. However, vaginal administration of progesterone is associated with vaginal irritation, discharge and bleeding. For all these reasons, there is a need for an effective, well tolerated, and safe treatment that can improve patient satisfaction and compliance. Many studies have observed similar pregnancy rate results with dydrogesterone and micronized vaginal progesterone. A new RCT including a total of 1143 patients by Tournaye, showed that dydrogesterone treatment had a similar safety profile to micronized vaginal progesterone (MVP) for luteal support as part of ART treatment. The crude pregnancy rates at 12 weeks were 37.6% and 33.1% in the dydrogesterone and MVP treatment groups respectively. Regarding the administration route of progesterone, intramuscular and transvaginal routes are the two conventional progesterone administration techniques. However, very few studies have compared the advantages of oral dydrogestrone with vaginal progesterone for luteal support in ART cycles. The objective of the investigator's study is to demonstrate the superiority of oral dydrogesterone (Duphaston) 10 over MVP (Utrogestan) used for luteal supplementation in cryo-warmed embryo transfer cycles. Upon consent, 224 patients women will be randomly allocated into either one of the study groups using a simple randomization method by computer-generated random numbers. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.

Conditions

Sterility; Infertility

Keywords

Luteal Phase Support; Cryo-warmed Embryo Transfer; Assisted Reproductive Technology

Outcome Measures

Primary Outcomes (1)

• Live births per embryo transferred

  Number of live births per number of embryos transferred

  until date of delivery

Secondary Outcomes (4)

• Ongoing or Clinical pregnancy rate per started treatment cycle (CPR)

  20 weeks from Last Menstrual Period (LMP)

• Implantation rate (IR)

  7 weeks from LMP

• Miscarriage rates

  From a positive pregnancy test till 12 weeks gestation

• Multiple gestation rate

  6-7 weeks of gestation

Study Arms (2)

Oral Dydrogesterone

EXPERIMENTAL

Oral dydrogesterone (Duphaston 10 mg) will be given orally four times daily : will be continued till the pregnancy test, and till at least 12 weeks of gestation in case of a positive pregnancy test.

Drug: Progesterone

Vaginal microprogesterone

EXPERIMENTAL

Vaginal progesterone (Utrogestan 200 mg) will be given vaginally four times daily: will be continued till the pregnancy test, and till at least 12 weeks of gestation in case of a positive pregnancy test

Drug: Progesterone

Interventions

Progesterone DRUG

Patients will be randomly assigned during the treatment follow up, at the time of addition of progesterone to the regimen, following computerized random number generator in procedure, to one of the study groups. Patients will be aware of the allocated arm since the treatment drugs have different route of administration. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.

Oral Dydrogesterone; Vaginal microprogesterone

Eligibility Criteria

• Age: 18 Years - 38 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Normal uterine cavity
• Normal Hormonal investigation: TSH,PRL,FBS
• Frozen embryo transfer cycles: at least 2 embryos
• Primary or secondary infertility: tubal occlusion, male factor, unexplained, endometriosis, ovarian factors…
• Body mass index (BMI) ≥18 to ≤30 kg/m2

You may not qualify if:

• Preexisting untreated medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition…)
• History of three or more consecutively failed In Vitro Fertilization (IVF) cycles after embryo transfer
• History of three or more miscarriages
• Previous allergy reactions to progesterone products

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Infertility

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

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: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 8, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

LE (1)