AzTrials
AzTrials

Infertility, FemaleNCT06304220

Comparison of Two PPOS Models for Pituitary Suppression

A study testing Cerazet in people with Infertility, Female and Fertility Disorders, run by NextFertility at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Read more about this study

Who is it for?
Ages 18 to 34 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Female, Fertility Disorders
What is being tested?
Cerazet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteSpain
Study dates
Jul 2024to Dec 2024
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 34 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • BMI of 18-29,9 kg/m2
  • Ultrasound count of antral follicles prior to COH ≥ 12 follicles
  • Meeting the criteria for inclusion in the egg donation program
  • Normal karyotype and no active sexually transmitted diseases
  • No use of combined hormonal contraceptives one month before COH

Who cannot join

  • Patients excluded from the egg donation program
  • Untreated sexually transmitted diseases, positive serology for HBV, HIV, HCV
  • Blood disorders, neurodegenerative/psychiatric diseases, carriers of X-linked genetic diseases, oncological diseases, endometriosis.
  • Oligomenorrhea (<1 menstrual cycle in 3 months)
  • Use of combined hormonal contraceptives before COH

Trial locations and contacts

1 site in 1 country.

Luis Quintero contact

+34 963160240

luis.quintero@next-clinics.com

Spain1 site

  • NextFertility

    Valencia, Valencia, 46009

    Luis Quintero, +34 963160240, luis.quintero@next-clinics.com

Other trials in Spain

About this study

Official title: Comparación de Dos Modelos de PPOS Para supresión Hipofisaria en Ciclos de estimulación ovárica, Desogestrel vs Medroxiprogesterona

The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients.

Read the detailed description

This is a multicenter, randomized, controlled clinical study comparing two different progestogens for pituitary suppression in normo-responding patients undergoing controlled ovarian hyperstimulation (COH) for egg donation. Patients will be recruited on the day they begin the egg donation program. Before inclusion, patients must meet all inclusion and exclusion criteria and provide written informed consent. Each patient will be assigned a patient code based on the treatment group they are included in. Treatment with the assigned progestogens will start on the first day of COH. The standard protocol for egg donation will be followed, including stimulation with FSHr (Puregon®), pituitary suppression with either Medroxyprogesterone acetate (Progevera®) or Desogestrel (Cerazet®), and trigger with GnRH agonist (Triptorelin acetate, Decapeptyl®) 36 hours before oocyte retrieval. Patients will continue taking the assigned progestogen throughout the COH period. Oocyte quality will be assessed based on maturity and morphology, with mature oocytes classified as normal or good quality and abnormal oocytes categorized into intracytoplasmic and extracytoplasmic abnormalities. Quality assessment will be performed by two blinded embryologists.

Being tested
Cerazet
Keywords
Primed-progestin ovarian stimulation protocol, Quality of oocytes, Oocyte yield, Ovarian Sensitivty Index, Controlled ovarian hyperstimulation
Medical subject headings
Infertility, Female

What participants receive

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

  • CerazetDrug

    Also called Progevera

    Comparation of the utilization of two distinct progestogens for pituitary suppression

Study groups in NCT06304220
Study groupRoleWhat they receive
Group DSG: DesogestrelActive comparatorDesogestrel Cerazet® 75 mg/day orally from the first day of controlled ovarian hyperstimulation (COH) until the day of trigger with agonist (GnRH-a).
Receives: Drug: Cerazet
Group MPA: MedroxyprogesteroneActive comparatorMedroxyprogesterone acetate Progevera® 10 mg/day orally from the first day of controlled ovarian hyperstimulation (COH) until the day of trigger with agonist (GnRH-a).
Receives: Drug: Cerazet

What is being measured

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

  1. Total number of oocytes retrieved from follicular puncture

    The total number of oocytes retrieved from the follicular puncture shall be counted.

    Measured: 5 months

  2. Number of mature oocytes (MII) retrieved from follicular puncture

    The number of mature oocytes (MII) recovered from the follicular puncture shall be counted.

    Measured: 5 months

Secondary outcomes (3)

  1. Oocyte quality variables

    Oocyte morphology will be assessed following the standard grading system established in Next Fertility, according to the criteria mentioned above.

    Measured: 5 months

  2. Ovarian sensitivity index (OSI

    total dose of gonadotrophin used/total number of MII oocytes obtained) x 1000

    Measured: 5 months

  3. Follicles

    Number of basal antral follicles of each size at the time of starting COH, Total number of follicles on the day of the second control and Number of follicles at the time of administering the trigger.

    Measured: 5 months

Timeline

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

  1. First posted12 Mar 2024
  2. Study startJul 2024 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionDec 2024 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, and controlled clinical study with two different progestogens: desogestrel 75 mg and medroxyprogesterone acetate 10 mg.
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06304220
Sponsor's protocol ID
MedroGestrel
Status last verified
Jun 2024
First submitted
26 Feb 2024
Last updated
18 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • La 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

  • Massin N. New stimulation regimens: endogenous and exogenous progesterone use to block the LH surge during ovarian stimulation for IVF. Hum Reprod Update. 2017 Mar 1;23(2):211-220. doi: 10.1093/humupd/dmw047.

    PubMed 28062551

  • Martinez F, Rodriguez-Purata J, Clua E, Garcia S, Coroleu B, Polyzos N. Ovarian response in oocyte donation cycles under LH suppression with GnRH antagonist or desogestrel progestin: retrospective and comparative study. Gynecol Endocrinol. 2019 Oct;35(10):884-889. doi: 10.1080/09513590.2019.1604662. Epub 2019 May 12.

    PubMed 31081407

  • Martinez F, Rodriguez-Purata J, Beatriz Rodriguez D, Clua E, Rodriguez I, Coroleu B. Desogestrel versus antagonist injections for LH suppression in oocyte donation cycles: a crossover study. Gynecol Endocrinol. 2019 Oct;35(10):878-883. doi: 10.1080/09513590.2019.1604661. Epub 2019 May 7.

    PubMed 31062995

  • Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.

    PubMed 30927417

  • Phillips A, Hahn DW, Klimek S, McGuire JL. A comparison of the potencies and activities of progestogens used in contraceptives. Contraception. 1987 Aug;36(2):181-92. doi: 10.1016/0010-7824(87)90013-8.

    PubMed 3427965

  • Mikkelsen AL, Lindenberg S. Morphology of in-vitro matured oocytes: impact on fertility potential and embryo quality. Hum Reprod. 2001 Aug;16(8):1714-8. doi: 10.1093/humrep/16.8.1714.

    PubMed 11473970

  • Rienzi L, Ubaldi FM, Iacobelli M, Minasi MG, Romano S, Ferrero S, Sapienza F, Baroni E, Litwicka K, Greco E. Significance of metaphase II human oocyte morphology on ICSI outcome. Fertil Steril. 2008 Nov;90(5):1692-700. doi: 10.1016/j.fertnstert.2007.09.024. Epub 2008 Feb 4.

    PubMed 18249393

  • Kazemi A, Ramezanzadeh F, Nasr-Esfahani MH. The relations between dietary antioxidant vitamins intake and oxidative stress in follicular fluid and ART outcomes. Iran J Reprod Med. 2015 Sep;13(9):533-40.

    PubMed 26568757

  • Gaskins AJ, Afeiche MC, Wright DL, Toth TL, Williams PL, Gillman MW, Hauser R, Chavarro JE. Dietary folate and reproductive success among women undergoing assisted reproduction. Obstet Gynecol. 2014 Oct;124(4):801-809. doi: 10.1097/AOG.0000000000000477.

    PubMed 25198264

Questions about this trial

What is this clinical trial studying?

A study testing Cerazet in people with Infertility, Female and Fertility Disorders, run by NextFertility at 1 site in Spain.

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 5 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 18 Jun 2024. 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 Spain. 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?

Results are not available in the source record.

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

Contact Luis Quintero (+34 963160240, luis.quintero@next-clinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total number of oocytes retrieved from follicular puncture (time frame: 5 months). The study lists 2 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 NCT06304220, which also lists 10 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 18 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in