Addition of Dydrogesterone to the Luteal Phase Support After Fresh Embryo Transfer

Infertility Clinical Trial

Official title:

Effectiveness of Treatment With Additional Dydrogesterone (Duphaston) to the Standard Luteal Phase Support After Fresh Embryo Transfer: a Prospective Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04408144
• Other study ID #: 0003-20-LND
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2021
• Source: Laniado Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized controlled study, open label to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.

Description:

In the context of IVF treatment, it's a standard of care to use progesterone for endometrial synchronization and for luteal phase support after embryos transfer and until week 9-12 of pregnancy.

In Israel, as in most european countries, vaginal insert of Micronised Vaginal Progesterone (MVP) is mostly prescribed.

Dydrogesterone is a potent active progesterone receptor agonist that is well tolerated, orally administered and is considered to be sufficiently safe during pregnancy.

Based on recent publications, single oral dydrogesterone treatment seems to be a good option in clinical practice for luteal phase support in IVF cycles with fresh embryos transfer.

But, until now, there is no publication evaluating the effectiveness of an addition of Dydrogesterone to the standard of care.

The aim of the study is to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.

The trial is a randomized controlled study, open label. Participants will receive either standard treatment with an addition of oral 10mg dydrogesterone (Duphaston) 2 times daily or the standard treatment without Dydrogesterone, starting on the day of fresh embryos transfer until 10 weeks of gestation or until pregnancy test is negative.

Study participation will be proposed to every woman going through fresh embryos transfer in Laniado IVF unit, who meets the inclusion/exclusion criteria.

The investigators aim to include 150 patients in each arm of the study, during 2 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients with a documented history of infertility who underwent IVF with or without ICSI, going through embryos transfer (having in the past up to 2 previous embryos transfer) and who gave written informed consent.

• Body mass index =18 to =35 kg/m2

• LH, prolactin (PRL), testosterone and thyroid-stimulating hormone (TSH) within normal clinical limits or not considered clinically significant within 1 year prior to or at screening

• Normal transvaginal ultrasound at screening (or within 14 days prior to screening)

• Planning a transfer of 1 or 2 fresh embryos.

Exclusion Criteria:

• Previous participation in this trial

• Subjects with >2 unsuccessful IVF attempts

• Evidence of head, ear, eye, nose, throat, cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine or neurologic/psychiatric disorders;

• Recent major surgery (within 3 months);

• Current or recent substance abuse, including that of alcohol and tobacco;

• History of chemotherapy;

• History of recurrent pregnancy loss (=3 previous miscarriages)

Related Conditions & MeSH terms

• Infertility
• IVF

Intervention

Drug:
• Dydrogesterone 10mg Oral Tablet
oral 10mg dydrogesterone (Duphaston) 2 times daily

Locations

Country	Name	City	State
Israel	Laniado Hospital	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Laniado Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events	Adverse Events (AES) and Serious Adverse Events (SAES) will be recorded during all the study period	3 years
Primary	Live birth rate	The percentage of live newborns in the total cycles of treatment	9 month
Secondary	Presence of fetal heartbeats at 12 weeks of gestation	The percentage of pregnancies with heartbeats observed by ultrasound at 12 weeks in the total cycles of treatment	12 weeks
Secondary	Frequency of positive pregnancy tests on Day 14 after embryo transfer		14 days
Secondary	Rates of obstetrical complications	Obstetrical complications during pregnancy and labor. Examples- abruptio placenta, First trimester bleeding, Preterm Prelabor Rupture Of Membranes (PPROM), preterm labor	9 months
Secondary	Newborn outcomes	Appearance, Pulse, Grimace, Activity and Respiration (APGAR) score- between 0-10. 10 is the best outcome. 0 is the worst outcome.	1 year
Secondary	Newborn Weight	in grammes	9 months
Secondary	Rates of Newborn malformations	Abnormal findings of physical examination of the newborn	1 year