Clinical trial · Interventional
Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss
Ultrasound Characterization of Ovarian Follicle Dynamics During Weight Loss
NCT01785719CI-TRIAL-00085397completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to explore the effects of weight loss on body composition, metabolic status, reproductive hormones, and ovarian follicle development in obese women with regular menstrual cycles versus obese women with irregular menstrual cycles and/or polycystic ovary syndrome (PCOS).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Amenorrhea | — | UNRESOLVED | — |
| Anovulation | — | UNRESOLVED | — |
| Infertility | — | UNRESOLVED | — |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Commercial Weight Loss Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Overweight Women
- description
- Regardless of reproductive history, each participant will be provided with six months of the commercial weight loss program, Nutrisystem® D. Nutrisystem® D is a portion-controlled, low calorie, and low glycemic index meal delivery system that provides 1250-1500 kcal/day. It has been proven to help overweight adults achieve real and sustainable weight loss results. When meals and snacks are consumed as instructed, average weight loss is 1-2 lbs per week or 15-20% body weight by the end of six months. Nutrisystem® D offers a balanced meal plan that is consistent with the nutrition recommendations of the USDA for Americans and American Diabetes Association. Each participant will be encouraged to take a daily multivitamin to help meet her micronutrient needs on the program.
- interventionNames
- Behavioral: Commercial Weight Loss Program
Primary outcomes (1)
- measure
- Change From Baseline Ovulatory/Menstrual Function
- timeFrame
- Up to 7 months
- description
- Participants with irregular menstrual cycles at baseline were categorized as "responders" or "non-responders" based on any changes they experienced in menstrual cyclicity over the course of the intervention. "Responders" were defined as participants who shifted towards a more favorable menstrual cycle status over the course of the intervention. "Non-responders" were defined as participants who experienced no change or a shift to a less favorable menstrual cycle status over the course of the intervention. Menstrual cycle status categories were defined as "Amenorrhea" (mean cycle length\>90 days; least favorable), "Oligomenorrhea" (mean cycle length 36-90 days; unfavorable), and "Regular" (mean cycle length 21-35 days; most favorable). All participants with regular menstrual cycles at baseline maintained regular cycles over the course of the intervention and were therefore not included in this analysis.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * BMI ≥ 30.0 kg/m\*m. * Self-reported history of regular menstrual cycles, irregular menstrual cycles, or PCOS. * Absence of hormonal contraception, fertility therapy, or insulin-sensitizing medication in the three months prior to enrollment. Exclusion Criteria: * Pregnant, breastfeeding, or lactating * Lack of one or both ovaries and/or uterus * Previous diagnosis of bleeding disorder(s) or current use of blood thinners/anticoagulants * Vegan or gluten free * Soy or peanut allergy
References
Publications (3)
- DERIVEDCarter FE, Jarrett BY, Lee ND, Zaman N, Reich AM, Wilson KA, Oldfield AL, Vanden Brink H, Lujan ME. Changes in antral follicle dynamics following weight loss in women with polycystic ovary syndrome. Hum Reprod. 2025 Nov 1;40(11):2161-2171. doi: 10.1093/humrep/deaf169. PMID 40929646
- DERIVEDOldfield AL, Carter FE, Reeves RE, Jarrett BY, Vanden Brink H, Lujan ME. Impact of a hypocaloric dietary intervention on antral follicle dynamics in eumenorrheic women with obesity. Hum Reprod. 2024 Apr 3;39(4):801-811. doi: 10.1093/humrep/deae017. PMID 38335228
- DERIVEDOldfield AL, Vanden Brink H, Carter FE, Jarrett BY, Lujan ME. Obesity is associated with alterations in antral follicle dynamics in eumenorrheic women. Hum Reprod. 2023 Mar 1;38(3):459-470. doi: 10.1093/humrep/dead007. PMID 36708012