progesterone as luteal phase supplementation in frozen embryo transfer cycles
Conditions
Interventions
Trade Name: Duphaston 10 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: DYDROGESTERONE
CAS Number: 152-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
UZ Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate the efficacy of dydrogesterone 30 mg compared to MVP 800 mg daily for LPS in HRT FET cycles, as confirmed by visualization of fetal heart activity by pelvic ultrasound assessment of ongoing pregnancy at 12 weeks of gestation. ;Secondary Objective: •To investigate positive serum hCG rate, clinical pregnancy rate (defined as the presence of =1 gestational sac following transvaginal ultrasound), miscarriage rate before 12 weeks of gestation and between 12 to 22 weeks of gestation. •To investigate the live birth rate, pregnancy complications, time of delivery (gestational week), and newborn health and safety parameters, including congenital malformations. •To investigate the safety and tolerability of dydrogesterone 30 mg daily versus MVP 800 mg daily for LPS in FET cycles in ART. •To investigate patient reported outcomes such as convenience and global satisfaction of using dydrogesterone 30 mg versus MVP 800 mg daily for LPS in FET cycles in ART. •To systematically investigate the rate of preterm birth (<Week 37) and pre-eclampsia ;Primary end point(s): For the purposes of the primary endpoint, ongoing pregnancy will be confirmed by visualization of fetal heart activity via pelvic (vaginal/abdominal) ultrasound examination at 12 weeks of gestation.;Timepoint(s) of evaluation of this end point: 12 weeks pregnancy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Live birth rate and time of delivery - Tolerability and safety - Patient reported outcomes - Newborn wellbeing and safety - Biochemical pregnancy - Clinical pregnancy rate - Miscarriage rate - Rate of preterm birth (<Week 37) and pre-eclampsia - Occurrence of antenatal bleeding, ultrasonographic abnormalities, gestational diabetes, cholestasis - Implantation rate - Blastocyst development score - Number of cryopreserved embryos - Summary characteristics of COS cycle - HRT cycle outcomes ;Timepoint(s) of evaluation of this end point: Day 5-6 of LPS (Day of FET) Day 14-18 of LPS (Pregnancy test) Day 33-39 of LPS (Verification of pregnancy) Day 68-74 of LPS (Ongoing pregnancy) Week 21-22 of pregnancy 4-6 weeks post delivery | — |
Countries
Belgium
Contacts
Public ContactStudy nurse
UZ Brussel
Outcome results
None listed