NCT01894074

Brief Summary

This is a study to determine whether a low calorie diet using meal replacement shakes compared to current counseling about diet, followed by 3 cycles of clomiphene citrate (if needed) will result in: 1) improvements in ability to ovulate and achieve pregnancy either spontaneously or during 3 clomiphene citrate cycles 2) greater weight loss with reductions in waist and hip circumferences and improvements in hormones that are involved in allowing pregnancy to occur and hormones that are involved in metabolism, such as insulin and glucose (sugar) 3) improvements in other health conditions such as blood pressure, and emotional and physical well-being. Women eligible to participate will be between the ages of 18-35 with a BMI (ratio of weight in kg divided by height in m2) of ≥ 35≤45 kg/m2 who are seeking help for anovulatory infertility including women with a diagnosis of polycystic ovarian syndrome (PCOS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

July 2, 2013

Last Update Submit

December 3, 2015

Conditions

SubfertilityAnovulatoryObese

Keywords

SubfertilityAnovulatoryObeseWomen

Outcome Measures

Primary Outcomes (1)

  • Improvement in ovulatory cycling

    The rate of spontaneous cycling (detected by LH surge) or evidence of menses. Improvement in either unassisted and clomiphene-assisted ovulation (for up to and including 3 cycles of clomiphene citrate)

    24 months

Secondary Outcomes (1)

  • Metabolic State

    24 months

Other Outcomes (3)

  • Quality of Life

    24 months

  • Maternal Health

    24 months

  • Fetal Health

    36 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Lifestyle counseling:standard dietary education and counseling with a goal of reducing calories to 1500-1800 kcal/day

Behavioral: Placebo

Intensive Dietary Intervention

ACTIVE COMPARATOR

Intensive Dietary Intervention employing very low energy diet (800 kcal/day) x 12 weeks followed by transition to regular foodstuffs over 4-6 weeks.

Behavioral: Intensive Dietary Intervention

Interventions

Intensive Dietary InterventionBEHAVIORAL

Intensive dietary intervention of 800 kcal/day using liquid meal replacement for a total of 12 weeks to reduce weight to 15% from baseline weight.

Also known as: Very low energy diet
Intensive Dietary Intervention
PlaceboBEHAVIORAL

Lifestyle counseling: standard dietary education and counseling with a goal of reducing to 1500-1800 kcal/day

Also known as: Lifestyle counseling
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women
  • to 35 years old
  • Obese(BMI of ≥35≤45 kg/m2)
  • Infertility (12 months of unprotected intercourse without conception)
  • Ovulatory dysfunction (amenorrhea, irregular cycles, or progesterone level less than 10 ng/mL in the luteal phase)
  • Partner with semen analysis demonstrating at least 20 million sperm/mL, 50% motility, and normal morphology by Kruger criteria of 8%
  • Evidence of normal uterine anatomy and at least on patent tube documented by hysterosalpingogram or saline infusion sonogram.
  • Women with polycystic ovary syndrome

You may not qualify if:

  • Significant heart disease (coronary artery disease, Class II-VI Heart Failure, arrythmia)
  • Chronic Kidney Disease, Stage IV or greater
  • Significant gastrointestinal tract diseases (e.g. IBD)
  • Autoimmune disorders (e.g. systemic lupus erythematosus)
  • Neurological (e.g. Multiple Sclerosis)
  • Psychiatric disorders (Bipolar, Major Depression)
  • History of or current eating disorders or substance abuse
  • Endocrine disorders (Type 1 diabetes, adrenal, pituitary or uncontrolled thyroid disease)
  • HIV/AIDS
  • Significant anemia
  • History of or current clotting disorder
  • Cancer other than minor skin cancers
  • Other conditions that would complicated pregnancy.
  • Women will be excluded if they are taking anti-obesity drugs, or appetite suppressants within the last 2 months, or have had previous bariatric surgery.
  • Women will be excluded if they have used hormonal medications within the last 2 months, previous use of ovulation induction medications, have endometriosis by American Fertility Society (AFS) class III or IV, have an FSH \> 10 IU/mL or couples using donor sperm or are already pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMichigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

  • Clark AM, Thornley B, Tomlinson L, Galletley C, Norman RJ. Weight loss in obese infertile women results in improvement in reproductive outcome for all forms of fertility treatment. Hum Reprod. 1998 Jun;13(6):1502-5. doi: 10.1093/humrep/13.6.1502.

    PMID: 9688382BACKGROUND

  • Rothberg A, Lanham M, Randolph J, Fowler C, Miller N, Smith Y. Feasibility of a brief, intensive weight loss intervention to improve reproductive outcomes in obese, subfertile women: a pilot study. Fertil Steril. 2016 Oct;106(5):1212-1220. doi: 10.1016/j.fertnstert.2016.06.004. Epub 2016 Jun 20.

    PMID: 27336206DERIVED

MeSH Terms

Conditions

InfertilityAnovulationObesity

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amy E Rothberg, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Internal Medicine

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 9, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations

US(1)