Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04583150
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2020-02-17
Brief Title:
Ovarian Reserve and Bariatric Surgery
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evolution of Ovarian Reserve in Severely Obese Women After Bariatric Surgery
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BARIAOVO
Brief Summary:
The expansion of the obesity epidemic is accompanied with an increase in bariatric procedures in particular in women of reproductive age Severe obesity has negative effects on fertility and on in vitro fertilization IVF outcomes and the weight loss induced by the bariatric surgery BS is believed to reverse the deleterious impact of overweight and obesity on female fertility However research is limited to retrospective cohort studies small case-series and case-control studies Weight reduction has been shown to improve fecundity and hormonal state of a subgroup of obese patients with polycystic ovary syndrome PCOS In this population recent studies have demonstrated an increase of naturally conceived pregnancies following bariatric surgery However these studies have evaluated only short-term evolution of ovarian function and not all studies demonstrated improvements in fertility outcomes after BS Clearly more studies are needed regarding the effect of BS on obesity-related infertility and long-term outcome of ovarian function has to be assessed
Markers of ovarian reserve including Follicle Stimulating Hormone FSH antral follicle count AFC and anti-mullerian hormone AMH have been used to counsel patients regarding in their reproductive outcomes Serum AMH concentrations remain remarkably stable throughout the menstrual cycle which is a great advantage over other markers of fertility Various studies have evaluated the association between AMH and body mass index BMI but reported contradictory results Some of them have reported a significant inverse correlation between AMH and BMI but others found no relationship between AMH and BMI Scarce and small preliminary studies have been performed to evaluate AMH changes after surgical weight loss and showed a decrease in serum AMH
Markers of ovarian reserve including Follicle Stimulating Hormone FSH antral follicle count AFC and anti-mullerian hormone AMH have been used to counsel patients regarding in their reproductive outcomes Serum AMH concentrations remain remarkably stable throughout the menstrual cycle which is a great advantage over other markers of fertility Various studies have evaluated the association between AMH and body mass index BMI but reported contradictory results Some of them have reported a significant inverse correlation between AMH and BMI but others found no relationship between AMH and BMI Scarce and small preliminary studies have been performed to evaluate AMH changes after surgical weight loss and showed a decrease in serum AMH
Detailed Description:
Medical files of volunteers obese women consulting an endocrinologist nutritionist or a gynaecologist in each center will be screened and women fitting the inclusion criteria will be proposed to participate in the study These women will be enrolled and matched with obese women with planned bariatric surgery prospectively The matching for age 1 year and BMI category BMI 35-399 kgm² 40-499 kgm² and 50 kgm² of each woman in the surgery group with a control woman will be performed globally ie two matched women could belong to the same center or two different centers
This is a national prospective multicentre cohort study Obese women with planned BS matched for presurgical age and BMI with women with no planned BS
Subjects with planned bariatric surgery will be recruited in the nutrition departments All consecutive eligible patients will be considered for inclusion
Obese women with no planned bariatric surgery will be recruited in the same centers than the corresponding women with planned bariatric surgery but two matched women can belong to two different centers
All subjects will be followed 36-42 months according to the delay between inclusion and BS and AMH levels will be measured at baseline or preoperative time 12 24 and 36 months after baseline for controls and after BS for operated women
This is a national prospective multicentre cohort study Obese women with planned BS matched for presurgical age and BMI with women with no planned BS
Subjects with planned bariatric surgery will be recruited in the nutrition departments All consecutive eligible patients will be considered for inclusion
Obese women with no planned bariatric surgery will be recruited in the same centers than the corresponding women with planned bariatric surgery but two matched women can belong to two different centers
All subjects will be followed 36-42 months according to the delay between inclusion and BS and AMH levels will be measured at baseline or preoperative time 12 24 and 36 months after baseline for controls and after BS for operated women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None