Metformin in Intracytoplasmic Sperm Injection Cycles
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|ClinicalTrials.gov Identifier: NCT03088631|
Recruitment Status : Completed
First Posted : March 23, 2017
Last Update Posted : September 17, 2019
The relationship between serum progesterone level on the day of human chorionic gonadotropin administration and outcome of in vitro fertilization /intracytoplasmic sperm injection and embryo transfer has been controversial for several decades. some studies presented data against the negative effect of premature luteinization and reported that elevated serum progesterone had no adverse effect on pregnancy rates in fresh embryo-transfer cycles within different ovarian responses. However, most studies have evaluated the association between serum progesterone level and clinical outcome in fresh in vitro fertilization /intracytoplasmic sperm injection cycles and advocated that serum progesterone elevation on the day of human chorionic gonadotropin administration may adversely affect the clinical outcome by jeopardizing endometrial receptivity.
In addition, the underlying mechanism through which premature luteinization influences clinical outcomes is elusive. some proposed that premature luteinization cause impairment of the endometrial receptivity, which may indicate a change in the implantation window, is more likely to be affected than the oocyte.whereas some documented that the compromised quality of oocytes might also be a cause.
The cut-off point of premature luteinization is not well established until now. Premature luteinization has been variously defined based on serum P levels, with thresholds of 0.9-1.5 ng/mL being used.
Previous studies have shown that metformin inhibits the first steps of steroidogenesis dose-dependently reducing granulosa cells progesterone output. Moreover, other authors have recently reported that low dose metformin could improve in vitro fertilization outcome in non poly-cystic ovarian syndrome repeaters. So, considering the safety of this drug before pregnancy, metformin can be given to consenting patients from first ultrasound monitoring until ovulation triggering.
|Condition or disease||Intervention/treatment||Phase|
|Intracytoplasmatic Sperm Injection||Drug: Metformin Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Eligible women who gave their informed consent were randomized into two groups: (I) metformin group and (II) placebo group. Randomization was conducted using a computer generated table of random numbers with allocation concealment. Randomization was not changed after it had been done.|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Role of Metformin in Prevention of Premature Luteinization in Intracytoplasmic Sperm Injection Cycles|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||March 1, 2019|
|Actual Study Completion Date :||April 1, 2019|
|Active Comparator: Metformin group||
will receive metformin (1500 mg/day) starting with the commencement of oral contraceptive pills in the preceding cycle until the day of human chorionic gonadotropin triggering.
|Placebo Comparator: Placebo group||
will receive corn-flour placebo tablets (three tablets daily).
- Incidence of premature luteinization in both groups [ Time Frame: 12 days ]Serum progesterone measurement ≥ 1.5 ng/ml by Mini-vidas assay was used to diagnose cases of premature luteinization.
- ongoing pregnancy rate [ Time Frame: 12 weeks ]The number of cases with pregnancy more than 12 weeks of gestation divided by the cycles initiated per 100.
- Good quality embryo rate [ Time Frame: 20 days ]The number of good day 3 embryos per all two-pronuclear embryos.
- Progesterone-to-mature oocyte index (PMOI) [ Time Frame: 17 days ]calculated by dividing the serum P level (ng/ml) by the number of mature oocytes.
- Progesterone/estradiol ratio [ Time Frame: 12 days ]calculated as [progesterone (ng/mL) × 1000]/esatradiol (pg/mL)
- Implantation rate [ Time Frame: 7 weeks ]The number of gestational sacs observed by trans-vaginal ultrasound divided by the number of embryos transferred.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088631
|Women Health Hospital - Assiut university|
|Assiut, Egypt, 71111|