Patients who undergo artificial vitrified/warmed single blastocyst transfer cycles with low progesterone (defined as <10mcg/l) on day of embryo transfer.
Conditions
Interventions
Trade Name: Amelgen
Pharmaceutical Form: Vaginal tablet
INN or Proposed INN: PROGESTERONE
CAS Number: 57-83-0
Current Sponsor code: PROGESTERONE
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study population is aimed at a broad population undergoing IVF or ICSI treatment undergoing a single vitrified/warmed single transfer in an artificial prepared endometrium cycle. Subjects who meet all of the following will be considered eligible to participate in the clinical trial: • Informed consent form (ICF) dated and signed • Age = 18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from participation in this study: • Simultaneous participation in another clinical study • Previous participation in this study • Known reasons for impaired implantation (specifically: presence of an hydrosalpinx; presence of a type I, II or III fibroid; Asherman's syndrome; uterine malformations, intrauterine adhesions, = grade 3 endometriosis according to the ASRM classification, endometrial tuberculosis) • Repeated miscarriages (> 2 miscarriages) • Untreated and uncontrolled thyroid dysfunction • Tumors of the ovary, breast, uterus, pituitary or hypothalamus • Abnormal vaginal bleeding without a known/diagnosed cause • Ovarian cysts or enlarged ovaries • Fibroid tumors of the uterus incompatible with pregnancy • Malformations of the reproductive organs incompatible with pregnancy • Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin) • Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia • Ongoing pregnancy • Use of carbamazepine, rifampicin or phenytoin • Those unable to comprehend the investigational nature of the proposed study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the effect of an increased dose of vaginal progesterone supplementation (Amelgen ® 400 mg BID vs Amelgen ® 400 mg TID) on the ongoing pregnancy (fetal heartbeat during TVUS between week 6 and 8 of pregnancy) rate for patients undergoing IVF or ICSI treatment with a suboptimal serum progesterone level (defined as <10 mcg/l) on the day of blastocyst transfer in an artificial prepared endometrium cycle.;Secondary Objective: To assess - if the degree of endometrial impaction is associated with reproductive outcome - if progesterone level on the day of blastocyst transfer in an artificial prepared endometrium cycle (< 10 mcg/l versus = 10 mcg/l) is associated with reproductive outcome who are receiving standard of care (hence not Amelgen® 400 mg TID); - if intercourse frequency (registered by patient diary) is associated with progesterone level on the day of blastocyst transfer in an artificial prepared endometrium cycle and with reproductive outcome who are receiving standard of care (hence not Amelgen® 400 mg TID). - To evaluate patient comfort and side effects on the day of embryo transfer and day of the initial pregnancy test in patients undergoing IVF or ICSI treatment - To determine if there are patient characteristics that can predict low progesterone level at day of embryo transfer who are receiving standard of care (hence not Amelgen® 400 mg TID). ;Primary end point(s): The primary end point is the ongoing pregnancy rate. The diagnosis of an ongoing pregnancy is made if a fetal heartbeat is documented during TVUS between week 6 and 8 of pregnancy.;Timepoint(s) of evaluation of this end point: The diagnosis of an ongoing pregnancy is made if a fetal heartbeat is documented during TVUS between week 6 and 8 of pregnancy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points are: - the endometrial impaction as measured with TVUS on the day of the embryo transfer (D5) and possible impact on reproductive outcome (pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate (defined as fetal heartbeat during TVUS between week 6 and 8 of pregnancy), biochemical pregnancy rate, miscarriage rate) - the comparison of reproductive outcome (pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate (defined as fetal heartbeat during TVUS between week 6 and 8 of pregnancy), biochemical pregnancy rate, miscarriage rate) of subjects with progesterone levels above and below the 10 mcg/L threshold; - the intercourse frequency (registered by patient diary) and possible impact on progesterone levels and on reproductive outcome (pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate (defined as fetal heartbeat during TVUS between week 6 and 8 of pregnancy), biochemical pregnancy rate, miscarriage rate) Exploratory endpoints: - Patient comfort and side effects questionnaire on (1) the day of embryo transfer (D5) and (2) on the day of the initial pregnancy test (D16 (± 2 days)) (separate document) and the patient diary. Patient-reported perineal irritation Bleeding/spotting Other side effects (gastro-intestinal discomfort, headache, …) Sexual life and intercourse frequency ;Timepoint(s) of evaluation of this end point: Secondary endpoints: - Endometrial impaction as measured with TVUS on the day of the embryo transfer (ET) (D5) and possible impact on reproductive outcome - Comparison of reproductive outcome (pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate (defined as fetal heartbeat during TVUS between week 6 and 8 of pregnancy), biochemical pregnancy rate, miscarriage rate) of subjects with progesterone levels above and below the 10 mcg/L threshold - Intercourse frequency (registered by patient diary) and possible impact on progesterone levels and on reproducti | — |
Countries
Belgium
Contacts
Public ContactHIRUZ
Ghent University Hospital
Outcome results
None listed