The Effect of Metformin on Fecundability in an ART(Assisted Reproductive Technology) Setting - the Correlation to Uterine Flows
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|ClinicalTrials.gov Identifier: NCT02848950|
Recruitment Status : Not yet recruiting
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
The basis for obesity's impact on reproduction is not well characterised and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.
Insulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to determine if Metformin helps to increase fecundability by affecting the uterus in women undergoing ART. As a surrogate marker- flows in the uterus will be tested during the treatment.
|Condition or disease||Intervention/treatment||Phase|
|Infertility Female||Drug: Metformin||Phase 2|
Obesity has been long implicated in reduced reproductive potential and it has been shown to impair conception and implantation. However, the basis for this adverse effect is still obscure and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.
It is well established that insulin resistance is one of the main mechanisms of obesity's negative influences on the reproductive organs in females. Insulin sensitizers ameliorate insulin resistance in obese patients.
This study seeks to determine if Metformin ,an oral antidiabetic and insulin sensitizer, helps to increase fecundability by affecting the uterus in women undergoing frozen-thawed embryo transfer compared to the control group. As a surrogate marker- flows in the uterus will be tested during the treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Metformin on Fecundability in Obese Women Undergoing ART - the Correlation to Uterine Flow Parameters A Prospective Randomized Controlled Trial|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||July 2017|
Active Comparator: treatment
Supplementation of the study group with Metformin till the day of pregnancy confirmation
Other Name: glucophage
No Intervention: control
- pregnancy rate [ Time Frame: until the blood test for pregnancy, about 4-6 weeks ]
- The changes in Doppler blood flow indices in both uterine arteries [ Time Frame: until the blood test for pregnancy, about 4-6 weeks ]
- endometrial thickness change measured by millimeters [ Time Frame: until the blood test for pregnancy, about 4-6 weeks ]
- Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows [ Time Frame: until the blood test for pregnancy, about 4-6 weeks ]
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): NCT02848950
|Contact: nora gorhad shabso, firstname.lastname@example.org|
|Principal Investigator:||JOHNNY YOUNIS, PEOFESSOR||Head of Fertility unit, Poriya' Bar Ilan University|