ObeseNCT01325805
Efficacy of a Structured Weight Loss Program in Overweight Women With a History of Recurrent Pregnancy Loss
A study testing Structured Weight Loss Program and Routine Weight Loss Counseling in people with Obese and Overweight, run by Stanford University at 1 site in United States.
Trial summary
Overweight and obesity has been associated with a number of adverse pregnancy outcomes in women of reproductive age, including infertility and early pregnancy loss. Recent data suggests that overweight and obese patients are also at increased risk of recurrent pregnancy loss (RPL), a devastating condition that affects… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obese, Overweight, Miscarriage
- What is being tested?
- Structured Weight Loss Program and Routine Weight Loss Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2013
- 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 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unexplained recurrent pregnancy loss (2 or more prior miscarriages)
- BMI >=25 kg/m2
- Prepared to take 3 months ¡®time out¡± from attempting to conceive
- Ability to attend a one hour initial, then 30 minute follow-up nutrition/monitoring session - once per week for one month, then every other week for 2 months, then once then once per month for 3 months.
Who cannot join
- Age >=40 years
- Diagnosis of Type 1 or Type 2 Diabetes as defined by a fasting glucose >=126, or 2 hour glucose >=200 by a 75 gram oral glucose challenge
- Presence of an endocrine condition such as hyperprolactinemia, Cushing¡-s syndrome or untreated thyroid disease (defined as a TSH outside of the laboratory determined normal range)
- Desire to continue attempts to conceive for the duration of the program
- History of bariatric surgery
- Use of over-the-counter or prescribed weight loss medications with the exception of metformin
- Enrollment in another clinical trial (excluding surveys)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Pregnancy Outcomes in Overweight and Obese Women With a History of Recurrent Pregnancy Loss Randomized to a Structured Weight Loss Program Versus Routine Weight-Loss Counseling: A Pilot Study
Overweight and obesity has been associated with a number of adverse pregnancy outcomes in women of reproductive age, including infertility and early pregnancy loss. Recent data suggests that overweight and obese patients are also at increased risk of recurrent pregnancy loss (RPL), a devastating condition that affects 1% of the fertile population.
The investigators propose a prospective, randomized controlled trial in which overweight and obese patients with unexplained recurrent pregnancy loss are enrolled in a structured, 6 month, weight loss program or provided routine counseling regarding the importance of weight loss. Pregnancy outcomes will then be followed to assess miscarriage rates. Metabolic outcomes, such as lipid and glucose profiles, will also be evaluated.
Read the detailed description
The purpose of this study is to investigate the impact of a structured weight loss program versus traditional weight-loss counseling on pregnancy outcomes in women with recurrent pregnancy loss. The study protocol is as follows:
- Patients will be notified of study via flyer inserted into patient chart at initial clinic visit, physician referral or Stanford website. Patients expressing interest will have their charts reviewed to confirm that they meet all enrollment criteria. Potential subjects will then be contacted via phone and verbal consent to participate obtained.
- The participant will then have an office visit for consent signing and randomization. A formal weight will be obtained, the Beck Depression Inventory will be administered by Penny Donnelly, a self-administered questionnaire will be completed, and a basic laboratory evaluation, including a fasting lipid panel, alanine aminotransferase (ALT), fasting glucose and insulin levels, 2-hour glucose tolerance test, hemoglobin A1c and CRP will be preformed.
- The patients will then be randomized to traditional weight loss counseling (control group) or to the structured weight loss program (study group). Patients will be instructed to discontinue attempts at conception.
- Those patients randomized to the control group will receive the ACOG Patient Education pamphlets on obesity.
- Those patients randomized to the study group will have a formal evaluation and counseling by Dr. Sun Kim, a medical endocrinologist specializing in weight management. They will then be enrolled in a structured weight loss program.
- For all patients, a 3-month follow-up office visit will be scheduled. At this visit, a formal weight will be obtained, the Beck Depression Inventory will be re-administered by Penny Donnelly, a self-administered questionnaire will be completed, and a follow-up laboratory evaluation, including a fasting lipid panel, alanine aminotransferase (ALT), fasting glucose and insulin levels, 2-hour glucose tolerance test, hemoglobin A1c and CRP will be preformed. Patients will be informed that they may now being attempts to conceive.
- Patients randomized to the study group will continue in the structured weight loss program for 6 months.
- Six months after enrollment, all patients will have a telephone interview in which a close-out questionnaire will be administered and a final, self-reported weight will be obtained.
- Primary and secondary outcomes will be followed for 2.5 years after date of enrollment for all patients.
- Conditions
- Obese, Overweight, Miscarriage, Recurrent Pregnancy Loss
- Being tested
- Structured Weight Loss Program, Routine Weight Loss Counseling
- Keywords
- Miscarriage, Recurrent Pregnancy Loss, Obesity, Overweight, Diet
- Medical subject headings
- Obesity, Overweight, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Weight Loss ProgramBehavioural
Those patients randomized to the structured weight loss group will have a formal evaluation and counseling a medical endocrinologist specializing in weight management. The structured weight loss program will consist of meeting with a dietician who will guide them on following a hypocaloric diet with a calorie deficit of 750kcal/day. The weight loss goal will be to lose 1-1.5 pounds/week. The participants will receive teaching utilizing the American Diabetes Association Exchange Lists and will receive sample meal plans. In addition, participants will be seen by the dietitian once a week for a month, then every 2 weeks for 2 months, then once per month for 3 months. Patients randomized to the study group will continue in the structured weight loss program for 6 months.
Routine Weight Loss CounselingBehavioural
Participants randomized to the routine weight loss counseling group will receive the ACOG Patient Education pamphlets on obesity.
| Study group | Role | What they receive |
|---|---|---|
| Structured Weight Loss | Experimental | Women randomized to this arm will meet with a registered dietician regularly for review of calorie recommendations and food diary. As well as regular clinic visits to measure patients weight. Receives: Behavioral: Structured Weight Loss Program |
| Routine Weight Loss Counseling | Active comparator | Patients are counseled by a physicians about the impact of maternal weight on fertility and pregnancy outcomes. Receives: Behavioral: Routine Weight Loss Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Term live birth rate
Measured: 2.5 years
Secondary outcomes (9)
Weight loss - goal for weight loss defined as 5 percent of enrollment body weight lost
Measured: 6 months
Changes in triglyceride levels
Measured: 3 months
Changes in high density lipoprotein levels
Measured: 3 months
Changes in alanine aminotransferase (ALT) levels
Measured: 3 months
Changes in fasting insulin levels
Measured: 3 months
Changes in postprandial insulin levels
Measured: 3 months
Changes in fasting glucose levels
Measured: 3 months
Changes in postprandial glucose levels
Measured: 3 months
Changes in hemoglobin A1c levels
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Difficult to recruit, very poor compliance with interventions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Bunker Lathi, Stanford University
- Investigators
- Ruth Bunker Lathi, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325805
- Sponsor's protocol ID
- SU-03212011-7603
- Other IDs
- IRB Protocol Number 20001
- Status last verified
- Dec 2021
- First submitted
- 23 Mar 2011
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Practice Committee of tAmerican Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss. Fertil Steril. 2008 Nov;90(5 Suppl):S60. doi: 10.1016/j.fertnstert.2008.08.065.
PubMed 19007647Li TC, Makris M, Tomsu M, Tuckerman E, Laird S. Recurrent miscarriage: aetiology, management and prognosis. Hum Reprod Update. 2002 Sep-Oct;8(5):463-81. doi: 10.1093/humupd/8.5.463.
PubMed 12398226James PT. Obesity: the worldwide epidemic. Clin Dermatol. 2004 Jul-Aug;22(4):276-80. doi: 10.1016/j.clindermatol.2004.01.010.
PubMed 15475226Shirazian T, Raghavan S. Obesity and pregnancy: implications and management strategies for providers. Mt Sinai J Med. 2009 Dec;76(6):539-45. doi: 10.1002/msj.20148.
PubMed 20014418Rich-Edwards JW, Goldman MB, Willett WC, Hunter DJ, Stampfer MJ, Colditz GA, Manson JE. Adolescent body mass index and infertility caused by ovulatory disorder. Am J Obstet Gynecol. 1994 Jul;171(1):171-7. doi: 10.1016/0002-9378(94)90465-0.
PubMed 8030695Jensen MD. Medical management of obesity. Semin Gastrointest Dis. 1998 Oct;9(4):156-62.
PubMed 9822077Bolumar F, Olsen J, Rebagliato M, Saez-Lloret I, Bisanti L. Body mass index and delayed conception: a European Multicenter Study on Infertility and Subfecundity. Am J Epidemiol. 2000 Jun 1;151(11):1072-9. doi: 10.1093/oxfordjournals.aje.a010150.
PubMed 10873131van der Steeg JW, Steures P, Eijkemans MJ, Habbema JD, Hompes PG, Burggraaff JM, Oosterhuis GJ, Bossuyt PM, van der Veen F, Mol BW. Obesity affects spontaneous pregnancy chances in subfertile, ovulatory women. Hum Reprod. 2008 Feb;23(2):324-8. doi: 10.1093/humrep/dem371. Epub 2007 Dec 11.
PubMed 18077317Metwally M, Ong KJ, Ledger WL, Li TC. Does high body mass index increase the risk of miscarriage after spontaneous and assisted conception? A meta-analysis of the evidence. Fertil Steril. 2008 Sep;90(3):714-26. doi: 10.1016/j.fertnstert.2007.07.1290. Epub 2008 Feb 6.
PubMed 18068166Lashen H, Fear K, Sturdee DW. Obesity is associated with increased risk of first trimester and recurrent miscarriage: matched case-control study. Hum Reprod. 2004 Jul;19(7):1644-6. doi: 10.1093/humrep/deh277. Epub 2004 May 13.
PubMed 15142995Wang JX, Davies MJ, Norman RJ. Obesity increases the risk of spontaneous abortion during infertility treatment. Obes Res. 2002 Jun;10(6):551-4. doi: 10.1038/oby.2002.74.
PubMed 12055331Metwally M, Saravelos SH, Ledger WL, Li TC. Body mass index and risk of miscarriage in women with recurrent miscarriage. Fertil Steril. 2010 Jun;94(1):290-5. doi: 10.1016/j.fertnstert.2009.03.021. Epub 2009 May 12.
PubMed 19439294Clark 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.
PubMed 9688382
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcomes in Overweight and Obese Women With a History of Recurrent Pregnancy Loss Randomized to a Structured Weight Loss Program Versus Routine Weight-Loss Counseling: A Pilot Study
- ClinicalTrials.gov ID
- NCT01325805
- Acronym / sponsor ID
- SU-03212011-7603
- Conditions
- Obese, Overweight, Miscarriage, Recurrent Pregnancy Loss
- Keywords
- Miscarriage, Recurrent Pregnancy Loss, Obesity, Overweight, Diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult to recruit, very poor compliance with interventions
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overweight and obesity has been associated with a number of adverse pregnancy outcomes in women of reproductive age, including infertility and early pregnancy loss. Recent data suggests that overweight and obese patients are also at increased risk of recurrent pregnancy loss (RPL), a devastating condition that affects 1% of the fertile population.
The investigators propose a prospective, randomized controlled trial in which overweight and obese patients with unexplained recurrent pregnancy loss are enrolled in a structured, 6 month, weight loss program or provided routine counseling regarding the importance of weight loss. Pregnancy outcomes will then be followed to assess miscarriage rates. Metabolic outcomes, such as lipid and glucose profiles, will also be evaluated.
Detailed description
The purpose of this study is to investigate the impact of a structured weight loss program versus traditional weight-loss counseling on pregnancy outcomes in women with recurrent pregnancy loss. The study protocol is as follows:
- Patients will be notified of study via flyer inserted into patient chart at initial clinic visit, physician referral or Stanford website. Patients expressing interest will have their charts reviewed to confirm that they meet all enrollment criteria. Potential subjects will then be contacted via phone and verbal consent to participate obtained.
- The participant will then have an office visit for consent signing and randomization. A formal weight will be obtained, the Beck Depression Inventory will be administered by Penny Donnelly, a self-administered questionnaire will be completed, and a basic laboratory evaluation, including a fasting lipid panel, alanine aminotransferase (ALT), fasting glucose and insulin levels, 2-hour glucose tolerance test, hemoglobin A1c and CRP will be preformed.
- The patients will then be randomized to traditional weight loss counseling (control group) or to the structured weight loss program (study group). Patients will be instructed to discontinue attempts at conception.
- Those patients randomized to the control group will receive the ACOG Patient Education pamphlets on obesity.
- Those patients randomized to the study group will have a formal evaluation and counseling by Dr. Sun Kim, a medical endocrinologist specializing in weight management. They will then be enrolled in a structured weight loss program.
- For all patients, a 3-month follow-up office visit will be scheduled. At this visit, a formal weight will be obtained, the Beck Depression Inventory will be re-administered by Penny Donnelly, a self-administered questionnaire will be completed, and a follow-up laboratory evaluation, including a fasting lipid panel, alanine aminotransferase (ALT), fasting glucose and insulin levels, 2-hour glucose tolerance test, hemoglobin A1c and CRP will be preformed. Patients will be informed that they may now being attempts to conceive.
- Patients randomized to the study group will continue in the structured weight loss program for 6 months.
- Six months after enrollment, all patients will have a telephone interview in which a close-out questionnaire will be administered and a final, self-reported weight will be obtained.
- Primary and secondary outcomes will be followed for 2.5 years after date of enrollment for all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Weight Loss | Experimental | Behavioral: Structured Weight Loss ProgramWomen randomized to this arm will meet with a registered dietician regularly for review of calorie recommendations and food diary. As well as regular clinic visits to measure patients weight. |
| Routine Weight Loss Counseling | Active comparator | Behavioral: Routine Weight Loss CounselingPatients are counseled by a physicians about the impact of maternal weight on fertility and pregnancy outcomes. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Unexplained recurrent pregnancy loss (2 or more prior miscarriages)
- BMI >=25 kg/m2
- Prepared to take 3 months ¡®time out¡± from attempting to conceive
- Ability to attend a one hour initial, then 30 minute follow-up nutrition/monitoring session - once per week for one month, then every other week for 2 months, then once then once per month for 3 months.
Key exclusion criteria (7 listed)
- Age >=40 years
- Diagnosis of Type 1 or Type 2 Diabetes as defined by a fasting glucose >=126, or 2 hour glucose >=200 by a 75 gram oral glucose challenge
- Presence of an endocrine condition such as hyperprolactinemia, Cushing¡-s syndrome or untreated thyroid disease (defined as a TSH outside of the laboratory determined normal range)
- Desire to continue attempts to conceive for the duration of the program
- History of bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Weight Loss ProgramThose patients randomized to the structured weight loss group will have a formal evaluation and counseling a medical endocrinologist specializing in weight management. The structured weight loss program will consist of meeting with a dietician who will guide them on following a hypocaloric diet with a calorie deficit of 750kcal/day. The weight loss goal will be to lose 1-1.5 pounds/week. The participants will receive teaching utilizing the American Diabetes Association Exchange Lists and will receive sample meal plans. In addition, participants will be seen by the dietitian once a week for a month, then every 2 weeks for 2 months, then once per month for 3 months. Patients randomized to the study group will continue in the structured weight loss program for 6 months. | Behavioural | Structured Weight Loss |
| Routine Weight Loss CounselingParticipants randomized to the routine weight loss counseling group will receive the ACOG Patient Education pamphlets on obesity. | Behavioural | Routine Weight Loss Counseling |
Primary outcome
Term live birth rate
Time frame: 2.5 years
9 secondary outcomes
Weight loss - goal for weight loss defined as 5 percent of enrollment body weight lost
Time frame: 6 months
Changes in triglyceride levels
Time frame: 3 months
Changes in high density lipoprotein levels
Time frame: 3 months
Changes in alanine aminotransferase (ALT) levels
Time frame: 3 months
Changes in fasting insulin levels
Time frame: 3 months
Changes in postprandial insulin levels
Time frame: 3 months
Changes in fasting glucose levels
Time frame: 3 months
Changes in postprandial glucose levels
Time frame: 3 months
Changes in hemoglobin A1c levels
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Difficult to recruit, very poor compliance with interventions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Background: PubMed 19007647Practice Committee of tAmerican Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss. Fertil Steril. 2008 Nov;90(5 Suppl):S60. doi: 10.1016/j.fertnstert.2008.08.065.
- Background: PubMed 12398226Li TC, Makris M, Tomsu M, Tuckerman E, Laird S. Recurrent miscarriage: aetiology, management and prognosis. Hum Reprod Update. 2002 Sep-Oct;8(5):463-81. doi: 10.1093/humupd/8.5.463.
- Background: PubMed 15475226James PT. Obesity: the worldwide epidemic. Clin Dermatol. 2004 Jul-Aug;22(4):276-80. doi: 10.1016/j.clindermatol.2004.01.010.
- Background: PubMed 20014418Shirazian T, Raghavan S. Obesity and pregnancy: implications and management strategies for providers. Mt Sinai J Med. 2009 Dec;76(6):539-45. doi: 10.1002/msj.20148.
- Background: PubMed 8030695Rich-Edwards JW, Goldman MB, Willett WC, Hunter DJ, Stampfer MJ, Colditz GA, Manson JE. Adolescent body mass index and infertility caused by ovulatory disorder. Am J Obstet Gynecol. 1994 Jul;171(1):171-7. doi: 10.1016/0002-9378(94)90465-0.
- Background: PubMed 9822077Jensen MD. Medical management of obesity. Semin Gastrointest Dis. 1998 Oct;9(4):156-62.
- Background: PubMed 10873131Bolumar F, Olsen J, Rebagliato M, Saez-Lloret I, Bisanti L. Body mass index and delayed conception: a European Multicenter Study on Infertility and Subfecundity. Am J Epidemiol. 2000 Jun 1;151(11):1072-9. doi: 10.1093/oxfordjournals.aje.a010150.
- Background: PubMed 18077317van der Steeg JW, Steures P, Eijkemans MJ, Habbema JD, Hompes PG, Burggraaff JM, Oosterhuis GJ, Bossuyt PM, van der Veen F, Mol BW. Obesity affects spontaneous pregnancy chances in subfertile, ovulatory women. Hum Reprod. 2008 Feb;23(2):324-8. doi: 10.1093/humrep/dem371. Epub 2007 Dec 11.
- Background: PubMed 18068166Metwally M, Ong KJ, Ledger WL, Li TC. Does high body mass index increase the risk of miscarriage after spontaneous and assisted conception? A meta-analysis of the evidence. Fertil Steril. 2008 Sep;90(3):714-26. doi: 10.1016/j.fertnstert.2007.07.1290. Epub 2008 Feb 6.
- Background: PubMed 15142995Lashen H, Fear K, Sturdee DW. Obesity is associated with increased risk of first trimester and recurrent miscarriage: matched case-control study. Hum Reprod. 2004 Jul;19(7):1644-6. doi: 10.1093/humrep/deh277. Epub 2004 May 13.
- Background: PubMed 12055331Wang JX, Davies MJ, Norman RJ. Obesity increases the risk of spontaneous abortion during infertility treatment. Obes Res. 2002 Jun;10(6):551-4. doi: 10.1038/oby.2002.74.
- Background: PubMed 19439294Metwally M, Saravelos SH, Ledger WL, Li TC. Body mass index and risk of miscarriage in women with recurrent miscarriage. Fertil Steril. 2010 Jun;94(1):290-5. doi: 10.1016/j.fertnstert.2009.03.021. Epub 2009 May 12.
- Stanford Fertility \& Reproductive Medicine CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Bunker Lathi principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Weight Loss Program and Routine Weight Loss Counseling in people with Obese and Overweight, run by Stanford University 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 3 Jan 2022. 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 was stopped early (reason given: Difficult to recruit, very poor compliance with interventions). Results are not available in the source record.
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?
Term live birth rate (time frame: 2.5 years). 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 NCT01325805, which also lists 13 linked publications.
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 3 Jan 2022.