IVFPhase 4DEGOSNCT04728659
Desogestrel Versus GnRH Antagonist in IVF/ICSI
A Phase 4 study testing Desogestrel 0.075 MG and Orgalutran in people with IVF and Infertility, run by Casa di Cura Privata Villa Mafalda at 1 site in Italy.
Trial summary
Progestin primed ovarian stimulation (PPOS) has been shown to be effective in avoiding premature spontaneous ovulation, without affecting the number of retrieved oocytes or the quality of the embryos obtained. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- IVF, Infertility
- What is being tested?
- Desogestrel 0.075 MG and Orgalutran
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 28 Feb 2022
- Phase
- Phase 4
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- regular menstrual cycles over the previous 3-month period (25 - 35 days in duration)
- basal serum FSH concentration of no more than 10 IU/L
Who cannot join
- documented ovarian failure, including basal FSH above 10 IU/L or no antral follicles by ultrasound examination
- diagnosis of polycystic ovarian syndrome
- any controindication to ovarian stimulation treatment.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Villa Mafalda
Roma
Ermanno Greco, MD, +39335304960, ergreco1@virgilio.it
About this study
Official title: Desogestrel Versus GnRH Antagonist (Ganirelix) in IVF/ICSI Patients Undergoing Ovarian Stimulation: a Randomized Controlled Trial
Progestin primed ovarian stimulation (PPOS) has been shown to be effective in avoiding premature spontaneous ovulation, without affecting the number of retrieved oocytes or the quality of the embryos obtained. The utilization of progestins permits lower costs, an easier administration (oral assumption instead of injections) and a tight control over LH levels. Hence the PPOS may be a valid alternative to the standard ovarian stimulation protocols.
Additionally, it may be anticipated some degree of superiority of PPOS in particular categories of patients: donors, women at risk of OHSS, women who preserve their as well as poor responder or suboptimal responders for whom oocytes/embryo accumulation or double ovarian stimulation protocols are proposed The aim of this trial will be to investigate the use of Desogestrel in controlling the LH surge during ovarian stimulation in IVF/ICSI cycles. This study is a noninferiority trial in which the the primary efficacy endpoint will be the number of oocytes retrieved per patient.
Sample size calculation was performed with the assumptions that the non-inferiority margin is corresponding to three or less oocytes . With the objective to demonstrate that the difference in average number of oocytes retrieved between the Desogestrel and the ganirelix groups would not exceed three, the power for a comparison between the two groups would be equal to 87% for 75 evaluable patients in each treatment groups (for an allocation of 1:1 and a total sample size of 150). To allocate at least 150 patients, an additional 10% to cover possible dropping out were planned to allocate. A total of 165 patients will be included in this study Patients will be assigned to either the study or the control group. The study group will be administered follitropin alfa (Bemfola 150-225 IU/die) and Desogestrel (Cerazette 75 mcg daily ) will be started on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. An antagonist protocol will be used for the control group. Patients will be administered follitropin alfa (Bemfola 150 - 225 IU/die) and Ganirelix (Orgalutran 0.25 mg/die) will be started on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. When a diameter of 18 mm is reached, the final stage of oocyte maturation will be triggered with triptorelin 0.2 mg + hCG 1000 U s.c. Fertilization of the aspirated oocytes will be carried out in vitro, by either conventional insemination or ICSI, depending on semen parameters. Viable embryos will be then frozen by means of vitrificaton on the day in which they will reach the blastocyst developmental stage.
Read the detailed description
Study design A prospective controlled randomized clinical trial (RCT) will be conducted to assess the non inferiority of Desogestrel (75 mcg) versus a flexible GnRH antagonist protocol with ganirelix (0.25 mg/day) in ovarian stimulation cycles.All partecipants will provide informed consent after counselling for infertility treatments and routine IVF procedures.
This will be a prospective non-inferiority trial. Given the possibility of dropouts, the study will be designed to include a total of 165 patients Patients will be recruited consecutively and allocated to one of the two groups in alternating manner.
Sample size The number of oocytes retrieved will be the primary efficacy endpoint of the study. Sample size calculation was performed with the assumptions that the non-inferiority margin is corresponding to three or less oocytes . With the objective to demonstrate that the difference in average number of oocytes retrieved between the Desogestrel and the ganirelix groups would not exceed three, the power for a comparison between the two groups would be equal to 87% for 75 evaluable patients in each treatment groups (for an allocation of 1:1 and a total sample size of 150). To allocate at least 150 patients, an additional 10% to cover possible dropping out were planned to allocate.
Ovarian stimulation Patients will be screened using transvaginal ultrasound on menstrual cycle day 2 to 3 . Patients will be then assigned to either the study or the control group. The study group will be administered follitropin alfa ( Bemfola 150 - 225 UI/die) from day 2-3 onward. The initiating dose of follitropin alfa will be decided upon the antral follicle count (AFC). After 4-5 days, ultrasound examination will be performed and the dose of FSH will be adjusted according to follicle development. Ovulation inhibition will be performed using Desogestrel (Cerazette, 75 mcg) starting on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. When the dominant follicles will reach 18 mm in diameter, the final stage of oocyte maturation will be triggered with triptorelin (Decapetyl) 0.2 mg s.c and serum FSH, LH, E2 and P concentrations will be measured using patients' blood tests on the same day of oocyte maturation. Transvaginal ultrasound-guided oocyte retrieval will be conducted 34 - 36 hours after trigger. All follicles with diameter of more than 10 mm will be retrieved.
An antagonist protocol will be used for the control group. Patients will be administered follitropin alfa (Bemfola 150 - 225 IU/die) from day 2-3 onward, with the dose of FSH administration based on the same criteria as for the study group. After 4-5 days, ultrasound examination will be performed and the dose of FSH will be adjusted according to follicle development. Ovulation inhibition will be performed using ganirelix (Orgalutran, 0.25 mg/die) starting on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. When dominant follicles reach 14 mm in diameter. When a diameter of 18 mm is reached, the final stage of oocyte maturation will be triggered with triptorelin (Decapeptyl) 0.2 mg s.c and serum FSH, LH, E2 and P concentrations will be measured using patients' blood tests on the same day of oocyte maturation.
Fertilization of the aspirated oocytes will be carried out in vitro, by either conventional insemination or ICSI, depending on semen parameters. According to the number and regularity of the blastomers and the degree of embryonic fragmentation, good-quality embryos will be frozen by means of vitrificaton on the third day after oocyte retrieval, and non-top quality embryos will placed in extended culture, out of which good morphological grade blastocysts were frozen on day 5.
- Conditions
- IVF, Infertility
- Being tested
- Desogestrel 0.075 MG, Orgalutran
- Keywords
- ovulation, progestin, PPOS, GnRH antagonist
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desogestrel 0.075 MGDrug
It will be given orally for 3 to 5 days during FSH administration for ovarian stimulation
OrgalutranDrug
It will be given subcutaneously for 3 to 5 days during FSH administration for ovarian stimulation
| Study group | Role | What they receive |
|---|---|---|
| Desogestrel Group | Experimental | Ovulation inhibition will be performed using Desogestrel (75 mcg) starting on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first Receives: Drug: Desogestrel 0.075 MG |
| GnRH antagonist | Active comparator | Ovulation inhibition will be performed using ganirelix (Orgalutran, 0.25 mg/die) starting on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. Receives: Drug: Orgalutran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of retrieved oocyte
The number of retrieved oocytes after ovarian stimulation
Measured: 14 days after ovarian stimulation
Secondary outcomes (5)
Number of patients with LH surge
Spontaneous LH surge
Measured: During the 14 days of ovarian stimulation
cycle cancellation rate
number of cancelled cycles
Measured: 14 days after ovarian stimulation
number of embryos
number of embryos available per couple
Measured: 7 days after oocyte reatrieval
number of mature oocytes
number of mature oocytes
Measured: 14 days after ovarian stimulation
serum levels of progesterone
serum progesterone levels on the day of hCG
Measured: 14 days after ovarian stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Oct 2020
- Primary completion30 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
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 IVFStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Privata Villa Mafalda
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728659
- Sponsor's protocol ID
- 01/2020
- Acronym
- DEGOS
- Status last verified
- Jan 2021
- First submitted
- 30 Dec 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
La Marca A, Capuzzo M, Sacchi S, Imbrogno MG, Spinella F, Varricchio MT, Minasi MG, Greco P, Fiorentino F, Greco E. Comparison of euploidy rates of blastocysts in women treated with progestins or GnRH antagonist to prevent the luteinizing hormone surge during ovarian stimulation. Hum Reprod. 2020 Jun 1;35(6):1325-1331. doi: 10.1093/humrep/deaa068.
PubMed 32395749Ata B, Capuzzo M, Turkgeldi E, Yildiz S, La Marca A. Progestins for pituitary suppression during ovarian stimulation for ART: a comprehensive and systematic review including meta-analyses. Hum Reprod Update. 2021 Jan 4;27(1):48-66. doi: 10.1093/humupd/dmaa040.
PubMed 33016316La Marca A, Capuzzo M. Use of progestins to inhibit spontaneous ovulation during ovarian stimulation: the beginning of a new era? Reprod Biomed Online. 2019 Aug;39(2):321-331. doi: 10.1016/j.rbmo.2019.03.212. Epub 2019 Mar 29.
PubMed 31138494
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desogestrel Versus GnRH Antagonist (Ganirelix) in IVF/ICSI Patients Undergoing Ovarian Stimulation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04728659
- Acronym / sponsor ID
- DEGOS / 01/2020
- Conditions
- IVF, Infertility
- Keywords
- ovulation, progestin, PPOS, GnRH antagonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Casa di Cura Privata Villa MafaldaResearch network
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 28 Jan 2021 (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.
Progestin primed ovarian stimulation (PPOS) has been shown to be effective in avoiding premature spontaneous ovulation, without affecting the number of retrieved oocytes or the quality of the embryos obtained. The utilization of progestins permits lower costs, an easier administration (oral assumption instead of injections) and a tight control over LH levels. Hence the PPOS may be a valid alternative to the standard ovarian stimulation protocols.
Additionally, it may be anticipated some degree of superiority of PPOS in particular categories of patients: donors, women at risk of OHSS, women who preserve their as well as poor responder or suboptimal responders for whom oocytes/embryo accumulation or double ovarian stimulation protocols are proposed The aim of this trial will be to investigate the use of Desogestrel in controlling the LH surge during ovarian stimulation in IVF/ICSI cycles. This study is a noninferiority trial in which the the primary efficacy endpoint will be the number of oocytes retrieved per patient.
Sample size calculation was performed with the assumptions that the non-inferiority margin is corresponding to three or less oocytes . With the objective to demonstrate that the difference in average number of oocytes retrieved between the Desogestrel and the ganirelix groups would not exceed three, the power for a comparison between the two groups would be equal to 87% for 75 evaluable patients in each treatment groups (for an allocation of 1:1 and a total sample size of 150). To allocate at least 150 patients, an additional 10% to cover possible dropping out were planned to allocate. A total of 165 patients will be included in this study Patients will be assigned to either the study or the control group. The study group will be administered follitropin alfa (Bemfola 150-225 IU/die) and Desogestrel (Cerazette 75 mcg daily ) will be started on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. An antagonist protocol will be used for the control group. Patients will be administered follitropin alfa (Bemfola 150 - 225 IU/die) and Ganirelix (Orgalutran 0.25 mg/die) will be started on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. When a diameter of 18 mm is reached, the final stage of oocyte maturation will be triggered with triptorelin 0.2 mg + hCG 1000 U s.c. Fertilization of the aspirated oocytes will be carried out in vitro, by either conventional insemination or ICSI, depending on semen parameters. Viable embryos will be then frozen by means of vitrificaton on the day in which they will reach the blastocyst developmental stage.
Detailed description
Study design A prospective controlled randomized clinical trial (RCT) will be conducted to assess the non inferiority of Desogestrel (75 mcg) versus a flexible GnRH antagonist protocol with ganirelix (0.25 mg/day) in ovarian stimulation cycles.All partecipants will provide informed consent after counselling for infertility treatments and routine IVF procedures.
This will be a prospective non-inferiority trial. Given the possibility of dropouts, the study will be designed to include a total of 165 patients Patients will be recruited consecutively and allocated to one of the two groups in alternating manner.
Sample size The number of oocytes retrieved will be the primary efficacy endpoint of the study. Sample size calculation was performed with the assumptions that the non-inferiority margin is corresponding to three or less oocytes . With the objective to demonstrate that the difference in average number of oocytes retrieved between the Desogestrel and the ganirelix groups would not exceed three, the power for a comparison between the two groups would be equal to 87% for 75 evaluable patients in each treatment groups (for an allocation of 1:1 and a total sample size of 150). To allocate at least 150 patients, an additional 10% to cover possible dropping out were planned to allocate.
Ovarian stimulation Patients will be screened using transvaginal ultrasound on menstrual cycle day 2 to 3 . Patients will be then assigned to either the study or the control group. The study group will be administered follitropin alfa ( Bemfola 150 - 225 UI/die) from day 2-3 onward. The initiating dose of follitropin alfa will be decided upon the antral follicle count (AFC). After 4-5 days, ultrasound examination will be performed and the dose of FSH will be adjusted according to follicle development. Ovulation inhibition will be performed using Desogestrel (Cerazette, 75 mcg) starting on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. When the dominant follicles will reach 18 mm in diameter, the final stage of oocyte maturation will be triggered with triptorelin (Decapetyl) 0.2 mg s.c and serum FSH, LH, E2 and P concentrations will be measured using patients' blood tests on the same day of oocyte maturation. Transvaginal ultrasound-guided oocyte retrieval will be conducted 34 - 36 hours after trigger. All follicles with diameter of more than 10 mm will be retrieved.
An antagonist protocol will be used for the control group. Patients will be administered follitropin alfa (Bemfola 150 - 225 IU/die) from day 2-3 onward, with the dose of FSH administration based on the same criteria as for the study group. After 4-5 days, ultrasound examination will be performed and the dose of FSH will be adjusted according to follicle development. Ovulation inhibition will be performed using ganirelix (Orgalutran, 0.25 mg/die) starting on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. When dominant follicles reach 14 mm in diameter. When a diameter of 18 mm is reached, the final stage of oocyte maturation will be triggered with triptorelin (Decapeptyl) 0.2 mg s.c and serum FSH, LH, E2 and P concentrations will be measured using patients' blood tests on the same day of oocyte maturation.
Fertilization of the aspirated oocytes will be carried out in vitro, by either conventional insemination or ICSI, depending on semen parameters. According to the number and regularity of the blastomers and the degree of embryonic fragmentation, good-quality embryos will be frozen by means of vitrificaton on the third day after oocyte retrieval, and non-top quality embryos will placed in extended culture, out of which good morphological grade blastocysts were frozen on day 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desogestrel Group | Experimental | Drug: Desogestrel 0.075 MGOvulation inhibition will be performed using Desogestrel (75 mcg) starting on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first |
| GnRH antagonist | Active comparator | Drug: OrgalutranOvulation inhibition will be performed using ganirelix (Orgalutran, 0.25 mg/die) starting on stimulation day 7 or when the leading follicle will reach 14 mm, whichever comes first. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- regular menstrual cycles over the previous 3-month period (25 - 35 days in duration)
- basal serum FSH concentration of no more than 10 IU/L
Key exclusion criteria (3 listed)
- documented ovarian failure, including basal FSH above 10 IU/L or no antral follicles by ultrasound examination
- diagnosis of polycystic ovarian syndrome
- any controindication to ovarian stimulation treatment.
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 |
|---|---|---|
| Desogestrel 0.075 MGIt will be given orally for 3 to 5 days during FSH administration for ovarian stimulation | Drug | Desogestrel Group |
| OrgalutranIt will be given subcutaneously for 3 to 5 days during FSH administration for ovarian stimulation | Drug | GnRH antagonist |
Primary outcome
Number of retrieved oocyte
Time frame: 14 days after ovarian stimulation
The number of retrieved oocytes after ovarian stimulation
5 secondary outcomes
Number of patients with LH surge
Time frame: During the 14 days of ovarian stimulation
cycle cancellation rate
Time frame: 14 days after ovarian stimulation
number of embryos
Time frame: 7 days after oocyte reatrieval
number of mature oocytes
Time frame: 14 days after ovarian stimulation
serum levels of progesterone
Time frame: 14 days after ovarian stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Background: PubMed 32395749La Marca A, Capuzzo M, Sacchi S, Imbrogno MG, Spinella F, Varricchio MT, Minasi MG, Greco P, Fiorentino F, Greco E. Comparison of euploidy rates of blastocysts in women treated with progestins or GnRH antagonist to prevent the luteinizing hormone surge during ovarian stimulation. Hum Reprod. 2020 Jun 1;35(6):1325-1331. doi: 10.1093/humrep/deaa068.
- Background: PubMed 33016316Ata B, Capuzzo M, Turkgeldi E, Yildiz S, La Marca A. Progestins for pituitary suppression during ovarian stimulation for ART: a comprehensive and systematic review including meta-analyses. Hum Reprod Update. 2021 Jan 4;27(1):48-66. doi: 10.1093/humupd/dmaa040.
- Background: PubMed 31138494La Marca A, Capuzzo M. Use of progestins to inhibit spontaneous ovulation during ovarian stimulation: the beginning of a new era? Reprod Biomed Online. 2019 Aug;39(2):321-331. doi: 10.1016/j.rbmo.2019.03.212. Epub 2019 Mar 29.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desogestrel 0.075 MG and Orgalutran in people with IVF and Infertility, run by Casa di Cura Privata Villa Mafalda at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 28 Jan 2021. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ermanno Greco (+39335304960, ergreco1@virgilio.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of retrieved oocyte (time frame: 14 days after ovarian stimulation). 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 NCT04728659, 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 28 Jan 2021.