InfertilityDESCRTNCT03799107
Developmental Epidemiological Study of Children Born Through Reproductive Technology
An observational study of Infertility and Infertility, Female, run by University of California, San Francisco at 1 site in United States.
Trial summary
DESCRT will be a long-term study that both looks back in time, at successful pregnancies, and forward in time at early pregnancy and long-term as these children grow. Currently, there are limited data on the long-term effects of infertility and infertility treatments on children. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Infertility, Infertility, Female, Infertility, Male
- How many people
- 2,020 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2017to 30 Jun 2022
- Phase
- Observational
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrospective: - children conceived by parent(s) who sought evaluation/treatment for infertility Prospective: - people seeking evaluation/treatment for infertility
Who may be able to join
- children conceived by parent(s) who sought evaluation/treatment for infertility
- seeking evaluation/treatment for infertility
Who cannot join
- Children with chronic medical illnesses that prevent a study visit
- Prospective arm
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: The Developmental Epidemiological Study of Children Born Through Reproductive Technology
DESCRT will be a long-term study that both looks back in time, at successful pregnancies, and forward in time at early pregnancy and long-term as these children grow. Currently, there are limited data on the long-term effects of infertility and infertility treatments on children. There are some studies to suggest that these children may have altered metabolic profiles, but this study aims to be the largest study to answer this question.
Read the detailed description
Over the past 30 years, much of the research and clinical effort in the field of ART had to do with improving outcome in terms of successful pregnancy. However, as these rates have increased, attention is slowly turning to focus on the health of the resultant child. Short-term health complications, in particular birth defects,have been well-described. However, even this "hard" outcome has been difficult to characterize as studies used different methodologies, varied age of detection, and frequently didn't have an appropriate comparison group. When underlying parental factors and infertility are included in the analyses, the association is substantially weakened or disappears completely. This exemplifies the problems with much of the currently available research regarding childhood outcomes following ART. While the health of children born through these technologies is of critical public health interest, and of personal interest to families, only limited data exist.
In order to evaluate the potential risk to long-term health of children conceived through assisted reproductive technologies (ART) and non-IVF fertility treatments (NIFT), rigorous epidemiological methods, appropriate characterization of the exposure, standardized collection of outcome data, and appropriate comparison groups are required. The proposed Developmental Epidemiological Study of Children born through Reproductive Technology (DESCRT) is aimed to carefully address these important characteristics.
- Conditions
- Infertility, Infertility, Female, Infertility, Male, Infertility Primary, Infertility Secondary, Infertility Unexplained
- Medical subject headings
- Infertility, Infertility, Female, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Children born with assistance | |
| Prospective | People who have sought evaluation/treatment for infertility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic testing of child - fasting glucose
Fasting glucose mg/dL
Measured: 1 day at study visit
Metabolic testing of child - fasting insulin
Fasting insulin uIU/mL
Measured: 1 day at study visit
Metabolic testing of child - uric acid
uric acid mg/dL
Measured: 1 day at study visit
Metabolic testing of child - total cholesterol
Cholesterol, Total mg/dL
Measured: 1 day at study visit
Metabolic testing of child - HDL cholesterol
HDL cholesterol mg/dL
Measured: 1 day at study visit
Metabolic testing of child - LDL cholesterol
LDL cholesterol mg/dL
Measured: 1 day at study visit
Metabolic testing of child - Triglycerides
Triglycerides mg/dL
Measured: 1 day at study visit
Metabolic testing of child - cholesterol ratio
CHOL/HDLC ratio
Measured: 1 day at study visit
Metabolic testing of child - non-HDL cholesterol
Non-HDL cholesterol mg/dL
Measured: 1 day at study visit
Metabolic testing of child - Alanine Aminotransferase
Alanine Aminotransferase (ALT) U/L
Measured: 1 day at study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start14 Jul 2017
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Marcelle Cedars, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799107
- Sponsor's protocol ID
- IRB 16-20474
- Other IDs
- 1R01HD084380
- Acronym
- DESCRT
- Status last verified
- Sep 2026
- First submitted
- 15 Nov 2018
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang D, Flynn E, Davidson B, Irwin JC, Naser M, Almonte AL, Qin J, Song Y, Rabara FB, Wong R, Zablotska LB, Rosen MP, Wittmann T, Fragiadakis GK, Combes AJ, Sirota M, Cedars MI, Giudice LC. Programmed cycle-induced endometrial perturbations do not independently influence angiogenic imbalance or hypertensive disorders in pregnancy. JCI Insight. 2026 Jun 23;11(15):e202443. doi: 10.1172/jci.insight.202443. eCollection 2026 Aug 10.
PubMed 42334867Huang D, Song Y, Qin J, Wong R, Durgana C, Adeleye A, Rinaudo P, Lustig RH, Zablotska LB, Cedars MI. Reappraisal of adverse obstetric outcomes independently associated with contemporary fertility treatment practices: a US prospective cohort study. Am J Obstet Gynecol. 2026 Jan;234(1):82-100. doi: 10.1016/j.ajog.2025.07.043. Epub 2025 Aug 5.
PubMed 40754175Adeleye AJ, Zablotska L, Rinaudo P, Huang D, Lustig RH, Cedars MI. Study protocol for a Developmental Epidemiological Study of Children born through Reproductive Technologies (DESCRT). Hum Reprod Open. 2023 May 5;2023(2):hoad013. doi: 10.1093/hropen/hoad013. eCollection 2023.
PubMed 37265937
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Developmental Epidemiological Study of Children Born Through Reproductive Technology
- ClinicalTrials.gov ID
- NCT03799107
- Acronym / sponsor ID
- DESCRT / IRB 16-20474
- Conditions
- Infertility, Infertility, Female, Infertility, Male, Infertility Primary, Infertility Secondary, Infertility Unexplained
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,020 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 10 Jan 2019 (actual)
- 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.
DESCRT will be a long-term study that both looks back in time, at successful pregnancies, and forward in time at early pregnancy and long-term as these children grow. Currently, there are limited data on the long-term effects of infertility and infertility treatments on children. There are some studies to suggest that these children may have altered metabolic profiles, but this study aims to be the largest study to answer this question.
Detailed description
Over the past 30 years, much of the research and clinical effort in the field of ART had to do with improving outcome in terms of successful pregnancy. However, as these rates have increased, attention is slowly turning to focus on the health of the resultant child. Short-term health complications, in particular birth defects,have been well-described. However, even this "hard" outcome has been difficult to characterize as studies used different methodologies, varied age of detection, and frequently didn't have an appropriate comparison group. When underlying parental factors and infertility are included in the analyses, the association is substantially weakened or disappears completely. This exemplifies the problems with much of the currently available research regarding childhood outcomes following ART. While the health of children born through these technologies is of critical public health interest, and of personal interest to families, only limited data exist.
In order to evaluate the potential risk to long-term health of children conceived through assisted reproductive technologies (ART) and non-IVF fertility treatments (NIFT), rigorous epidemiological methods, appropriate characterization of the exposure, standardized collection of outcome data, and appropriate comparison groups are required. The proposed Developmental Epidemiological Study of Children born through Reproductive Technology (DESCRT) is aimed to carefully address these important characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | –Children born with assistance |
| Prospective | – | –People who have sought evaluation/treatment for infertility |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective: - children conceived by parent(s) who sought evaluation/treatment for infertility Prospective: - people seeking evaluation/treatment for infertility
Key inclusion criteria (2 listed)
- children conceived by parent(s) who sought evaluation/treatment for infertility
- seeking evaluation/treatment for infertility
Key exclusion criteria (3 listed)
- Children with chronic medical illnesses that prevent a study visit
- Prospective arm
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic testing of child - fasting glucose
Time frame: 1 day at study visit
Fasting glucose mg/dL
Metabolic testing of child - fasting insulin
Time frame: 1 day at study visit
Fasting insulin uIU/mL
Metabolic testing of child - uric acid
Time frame: 1 day at study visit
uric acid mg/dL
Metabolic testing of child - total cholesterol
Time frame: 1 day at study visit
Cholesterol, Total mg/dL
Metabolic testing of child - HDL cholesterol
Time frame: 1 day at study visit
HDL cholesterol mg/dL
Metabolic testing of child - LDL cholesterol
Time frame: 1 day at study visit
LDL cholesterol mg/dL
Metabolic testing of child - Triglycerides
Time frame: 1 day at study visit
Triglycerides mg/dL
Metabolic testing of child - cholesterol ratio
Time frame: 1 day at study visit
CHOL/HDLC ratio
Metabolic testing of child - non-HDL cholesterol
Time frame: 1 day at study visit
Non-HDL cholesterol mg/dL
Metabolic testing of child - Alanine Aminotransferase
Time frame: 1 day at study visit
Alanine Aminotransferase (ALT) U/L
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Derived from this study: PubMed 42334867Huang D, Flynn E, Davidson B, Irwin JC, Naser M, Almonte AL, Qin J, Song Y, Rabara FB, Wong R, Zablotska LB, Rosen MP, Wittmann T, Fragiadakis GK, Combes AJ, Sirota M, Cedars MI, Giudice LC. Programmed cycle-induced endometrial perturbations do not independently influence angiogenic imbalance or hypertensive disorders in pregnancy. JCI Insight. 2026 Jun 23;11(15):e202443. doi: 10.1172/jci.insight.202443. eCollection 2026 Aug 10.
- Derived from this study: PubMed 40754175Huang D, Song Y, Qin J, Wong R, Durgana C, Adeleye A, Rinaudo P, Lustig RH, Zablotska LB, Cedars MI. Reappraisal of adverse obstetric outcomes independently associated with contemporary fertility treatment practices: a US prospective cohort study. Am J Obstet Gynecol. 2026 Jan;234(1):82-100. doi: 10.1016/j.ajog.2025.07.043. Epub 2025 Aug 5.
- Derived from this study: PubMed 37265937Adeleye AJ, Zablotska L, Rinaudo P, Huang D, Lustig RH, Cedars MI. Study protocol for a Developmental Epidemiological Study of Children born through Reproductive Technologies (DESCRT). Hum Reprod Open. 2023 May 5;2023(2):hoad013. doi: 10.1093/hropen/hoad013. eCollection 2023.
- 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.
Marcelle Cedars, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Infertility, Female, run by University of California, San Francisco 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 2 inclusion and 3 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 15 Sep 2026. 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?
Metabolic testing of child - fasting glucose (time frame: 1 day at study visit). The study lists 10 primary outcomes in all. 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 NCT03799107, which also lists 3 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 15 Sep 2026.