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Polycystic Ovary SyndromeNCT03677362

Weight Loss Intervention in Women With PCOS

A study testing Weight loss intervention in people with Polycystic Ovary Syndrome and Overweight and Obesity, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed single arm 6 mo. trial will assess the impact of weight loss and fat loss due to a multicomponent remotely-delivered lifestyle intervention on ovulation rates and time-to-ovulation in overweight and obese women with anovulatory infertility caused by PCOS. Read more about this study

Who is it for?
Ages 21 to 42 years, women only
What is being tested?
Weight loss intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
10 Sep 2018to 22 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 42 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Anovulatory infertility caused by Polycystic ovarian syndrome
  • Age 21 to 42.
  • Body mass index (BMI) > 25 to 45 kg/m2.
  • Weight stable (± 4.6 kg) in previous 3 months
  • Willing to delay fertility treatment for 6 mos

Who cannot join

  • Unable to participate in moderate-vigorous physical activity (i.e., brisk walking)
  • Currently participating in greater than 3, 30-minute bouts of planned PA/week
  • Participation in a weight loss or PA program in the previous 6 mos.
  • Currently on a weight loss medication (wash out period 2 mos.)
  • Any other infertility diagnosis besides ovulatory dysfunction
  • Binge eating disorder as assessed by the Binge Eating Scale.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

The proposed single arm 6 mo. trial will assess the impact of weight loss and fat loss due to a multicomponent remotely-delivered lifestyle intervention on ovulation rates and time-to-ovulation in overweight and obese women with anovulatory infertility caused by PCOS.

Read the detailed description

Obesity and visceral adiposity are associated with reproductive dysfunction, specifically infertility, problems with ovulation, and decreased rates of conception. Approximately 31% of reproductive aged women in the U.S. are obese. Obese women who become pregnant are at increased risk for miscarriage and pregnancy complications. Infertility treatment using assisted reproductive technologies such as fertility medications, in vitro fertilization or intracytoplasmic sperm injection, is time-intensive, costly, and less effective in obese compared with normal weight women. However, attempts at weight loss to date have been modest at best and the effectiveness of single component hypocaloric diets are questionable. A recently conducted large scale preconception weight loss study in the Netherlands randomized 577 obese infertile women to either a lifestyle intervention prior to fertility treatment or prompt fertility treatment. This study found significantly higher spontaneous pregnancies in the lifestyle intervention group compared to those who promptly received fertility treatment. Additionally, when post hoc analyses were completed on predetermined subgroups, researchers found women with anovulation had more spontaneous pregnancies compared to ovulatory women in the lifestyle intervention group. A few major limitations of this study include: 1) modest weight loss of 4.4 kg and only 38% obtained the minimum goal of 5% weight loss; 2) the study included women with a variety of infertility diagnoses; and 3) limited BMI range of 29-40 kg/m2. More prospective research is necessary to evaluate the effects of weight loss in anovulatory women caused by Polycystic ovarian syndrome (PCOS) as there may be larger benefits in this population such as restoration of ovulation and spontaneous conception. Additionally, there has been limited research investigating fat loss after a lifestyle intervention and the impact on ovulation. Fat loss may play a large role as the purported mechanism by which obesity influences ovulation is through insulin resistance and increased ovarian androgen secretion. Similar to other populations in need of lifestyle interventions, women seeking fertility treatment also have multiple barriers to weight management. Infertility treatment centers in major metropolitan cities often draw individuals from large geographical areas including rural dwelling individuals. Our research team has developed an efficacious weight management program that has shown superior weight loss compared to conventional treatment and has successfully been delivered remotely eliminating concerns of access and transportation and may be well suited for this unique population. However, the acceptability of a remote delivered weight loss intervention, attendance at behavioral sessions, compliance with diet and physical activity (PA) recommendations and self-monitoring (diet, PA, weight), as well as the impact of the magnitude of weight loss on ovulation rates in overweight and obese anovulatory women are unknown, and will be the focus of this study. Over a 2 mo. period, 20 overweight or obese women (BMI > 25 -45 kg/m2, age 21-38 yrs.) seeking initial treatment after 12 mos. of unsuccessful conception (~ 40 new women/mo.) will be recruited to complete a 6 mo. multicomponent weight loss intervention (WLI). Participants must be willing to withhold infertility treatment for the length of the 6 mo. intervention and have the diagnosis of ovulatory dysfunction (anovulation) caused by PCOS as the primary cause of infertility. In the WLI, energy intake will be prescribed at 1200-1500 kcal/d using commercially available portion-controlled entrées, low calorie shakes, fruits/vegetables, and ad-libitum non-caloric beverages. Participants will be asked to consume a minimum daily total of 2 entrées (~200 to 300 kcal each, saturated fat ≤ 3g), 3 shakes (~100 kcal each), five 1-cup servings of fruits/vegetables, and ad libitum non-caloric beverages. Additionally, they will be asked to complete 225 min of moderate intensity PA, and self-monitor diet, PA (self-report) and body weight (home scale) across the 6 mo. intervention. Weekly behavioral counseling sessions (45 min) via Skype will be delivered by a professional health educator (HE) to participants in their homes.

Being tested
Weight loss intervention
Medical subject headings
Polycystic Ovary Syndrome, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight loss interventionBehavioural

    In the WLI, energy intake will be prescribed at 1200-1500 kcal/d using commercially available portion-controlled entrées, low calorie shakes, fruits/vegetables, and ad-libitum non-caloric beverages. Participants will be asked to consume a minimum daily total of 2 entrées (~200 to 300 kcal each, saturated fat ≤ 3g), 3 shakes (~100 kcal each), five 1-cup servings of fruits/vegetables, and ad libitum non-caloric beverages. Additionally, they will be asked to complete 225 min of moderate intensity PA, and self-monitor diet, PA (self-report) and body weight (home scale) across the 6 mo. intervention. Weekly behavioral counseling sessions (45 min) via group phone callsSkype will be delivered by a professional health educator (HE) to participants in their homes.

Study groups in NCT03677362
Study groupRoleWhat they receive
Weight loss interventionExperimentalIn the WLI, energy intake will be prescribed at 1200-1500 kcal/d using commercially available portion-controlled entrées, low calorie shakes, fruits/vegetables, and ad-libitum non-caloric beverages. Participants will be asked to consume a minimum daily total of 2 entrées (~200 to 300 kcal each, saturated fat ≤ 3g), 3 shakes (~100 kcal each), five 1-cup servings of fruits/vegetables, and ad libitum non-caloric beverages. Additionally, they will be asked to complete 225 min of moderate intensity PA, and self-monitor diet, PA (self-report) and body weight (home scale) across the 6 mo. intervention. Weekly behavioral counseling sessions (45 min) via Skype will be delivered by a professional health educator (HE) to participants in their homes.
Receives: Behavioral: Weight loss intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ovulation

    Ovulation will be assessed weekly during the 6 mo. intervention by ovulation monitoring kit and the OvuSense device.

    Measured: 6 months

Secondary outcomes (2)
  1. Fertility related quality of life

    The fertility quality of life (FertiQoL) tool (questionnaire)

    Measured: Baseline and 6 months

  2. Body composition

    A dual energy x-ray absorptiometry scan will determine percent body fat.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2018
  2. Study start10 Sep 2018
  3. Primary completion22 Feb 2020
  4. Study completion22 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03677362
Sponsor's protocol ID
142744
Status last verified
Aug 2020
First submitted
13 Sep 2018
Last updated
1 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gorczyca AM, Steger FL, Ptomey LT, Montgomery RN, Mickelsen R, Smith P, Donnelly JE, Marsh CA. The impact of a group based, remotely delivered weight loss intervention in women with polycystic ovary syndrome on ovulation, quality of life and body composition. Front Reprod Health. 2022 Jul 22;4:940945. doi: 10.3389/frph.2022.940945. eCollection 2022.

    PubMed 36303658

Questions about this trial

What is this clinical trial studying?

A study testing Weight loss intervention in people with Polycystic Ovary Syndrome and Overweight and Obesity, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ovulation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03677362, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.

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