Infertility, FemaleNCT05577806
DYG Versus Cetrorelix in Oocyte Donation
An observational study of Infertility, Female and Fertility Disorders, run by Clinica de la Mujer Medicina Reproductiva, Chile.
Trial summary
Prospective controlled study to assess the reproductive outcomes of OD recipients in which the donors were subjected to the DYG protocol (20mg/day) compared with those subjected to the short protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm. Read more about this study
- Who is it for?
- Ages 21 to 30 years, women only
- Conditions the study is for
- Infertility, Female, Fertility Disorders
- What is being tested?
- Dydrogesterone
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2021
- 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 21 to 30 years
- Women only
- Adult
Study population: Oocyte donors undergoing controlled ovarian stimulation
Who may be able to join
- Oocyte donors between 21 and 30 years old, with regular menstrual cycles (24-35 d) and a body mass index (BMI) between 18 and 28 kg/m2 without any relevant personal or family history
Who cannot join
- AMH less than 3 ng/dL
- A positive screening for sexually transmitted diseases
About this study
Official title: Comparison of Reproductive Outcomes After Progestin-primed Ovarian Stimulation With Dydrogesterone Versus Cetrorelix to Inhibit Spontaneous Ovulation in Oocyte Donation
Prospective controlled study to assess the reproductive outcomes of OD recipients in which the donors were subjected to the DYG protocol (20mg/day) compared with those subjected to the short protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm. The OD cycles were triggered with triptoreline acetate and the trigger criterion was ≥3 follicles of diameter >18mm.
- Conditions
- Infertility, Female, Fertility Disorders
- Being tested
- Dydrogesterone
- Keywords
- Gonadotrophin-releasing hormone (GnRH) analogues, Ovarian stimulation, Oocyte donation, Progestin-primed ovarian stimulation, Dydrogesterone
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DydrogesteroneDrug
progestin primed ovarian stimulation
| Study group | Role | What they receive |
|---|---|---|
| DYG | oocyte donors undergoing controlled ovarian stimulation in a progestin-primed ovarian stimulation protocol with DYG protocol (20mg/day) Receives: Drug: Dydrogesterone | |
| Cetrorelix | oocyte donors undergoing controlled ovarian stimulation in a GnRH antagonist protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth Rate per transfer
Measured: 40 weeks after ET
Clinical pregnancy per transfer
Measured: 12 weeks after ET
Miscarriage rate
Measured: 12 weeks after ET
Secondary outcomes (4)
Number of oocytes retrieved
Measured: at time of oocyte retrieval
Number of mature oocytes
Measured: 1 day after IVF
Number of fertilized oocytes
Measured: 1 day after IVF
Number of blastocists
Measured: 5-6 days after OPU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Jan 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica de la Mujer Medicina Reproductiva, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Antonio Moreno, Clinica de la Mujer Medicina Reproductiva, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577806
- Sponsor's protocol ID
- PPOS-DU-OD
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Reproductive Outcomes After Progestin-primed Ovarian Stimulation With Dydrogesterone Versus Cetrorelix to Inhibit Spontaneous Ovulation in Oocyte Donation
- ClinicalTrials.gov ID
- NCT05577806
- Acronym / sponsor ID
- PPOS-DU-OD
- Conditions
- Infertility, Female, Fertility Disorders
- Keywords
- Gonadotrophin-releasing hormone (GnRH) analogues, Ovarian stimulation, Oocyte donation, Progestin-primed ovarian stimulation, Dydrogesterone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Clinica de la Mujer Medicina Reproductiva, ChileUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Oct 2022 (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.
Prospective controlled study to assess the reproductive outcomes of OD recipients in which the donors were subjected to the DYG protocol (20mg/day) compared with those subjected to the short protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm. The OD cycles were triggered with triptoreline acetate and the trigger criterion was ≥3 follicles of diameter >18mm.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DYG | – | Drug: Dydrogesteroneoocyte donors undergoing controlled ovarian stimulation in a progestin-primed ovarian stimulation protocol with DYG protocol (20mg/day) |
| Cetrorelix | – | –oocyte donors undergoing controlled ovarian stimulation in a GnRH antagonist protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Oocyte donors undergoing controlled ovarian stimulation
Key inclusion criteria (1 listed)
- Oocyte donors between 21 and 30 years old, with regular menstrual cycles (24-35 d) and a body mass index (BMI) between 18 and 28 kg/m2 without any relevant personal or family history
Key exclusion criteria (2 listed)
- AMH less than 3 ng/dL
- A positive screening for sexually transmitted diseases
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 |
|---|---|---|
| Dydrogesteroneprogestin primed ovarian stimulation | Drug | DYG |
Primary outcome
Live Birth Rate per transfer
Time frame: 40 weeks after ET
Clinical pregnancy per transfer
Time frame: 12 weeks after ET
Miscarriage rate
Time frame: 12 weeks after ET
4 secondary outcomes
Number of oocytes retrieved
Time frame: at time of oocyte retrieval
Number of mature oocytes
Time frame: 1 day after IVF
Number of fertilized oocytes
Time frame: 1 day after IVF
Number of blastocists
Time frame: 5-6 days after OPU
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 13 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Fertility Disorders, run by Clinica de la Mujer Medicina Reproductiva, Chile.
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 1 inclusion and 2 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 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Live Birth Rate per transfer (time frame: 40 weeks after ET). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2022.