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Infertility, FemaleOne-shotNCT06635538

One-shot Ovarian Stimulation Protocol (One-shot)

A study testing Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1, Clomiphene Citrate (CC) 100 mg/day from D1 and Monitoring cycle in people with Infertility, Female, run by Fundación Santiago Dexeus Font at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The current prospective observational pilot study aims to evaluate the endocrine profile of a single-injection protocol (single CFA + daily oral administration of CC). Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Infertility, Female
What is being tested?
Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1, Clomiphene Citrate (CC) 100 mg/day from D1 and Monitoring cycle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesSpain
Study dates
31 Oct 2024to 11 Nov 2025
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 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age <= 40
  • AMH (Anti-Mullerian Hormone) 1.2-3.5 ng/ml or AFC 7-20
  • No family history of hereditary or chromosomal diseases
  • Body mass index (BMI) 18 to 30 kg/m2

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

    Barcelona, 08037

  • Dexeus Mujer Sabadell

    Sabadell, Barcelona, 08203

  • Dexeus Mujer Sant Cugat

    Sant Cugat del Vallès, Barcelona, 08195

Other trials in Spain

About this study

Official title: One-Shot Ovarian Stimulation Protocol: A Pilot Study Investigating the Endocrine Profile

The current prospective observational pilot study aims to evaluate the endocrine profile of a single-injection protocol (single CFA + daily oral administration of CC).

Being tested
Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1, Clomiphene Citrate (CC) 100 mg/day from D1, Monitoring cycle
Medical subject headings
Infertility, Female

What participants receive

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

  • Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1Drug

    On day 2 or 3 of the menstrual cycle or after 5 days of pill-free interval, a single injection of 150 mcg of CFA (Stimulation Day 1) will be administered.

  • Clomiphene Citrate (CC) 100 mg/day from D1Drug

    On day 2 or 3 of the menstrual cycle or after 5 days of pill-free interval, the patients will start oral administration of Clomiphene Citrate 100/day continuing up to and including the day of ovulation triggering

  • Monitoring cycleDiagnostic test

    Scan controls and blood exams will be performed on stimulation days 1, 6, 8, 10 and, according to clinical needs, until trigger day.

Study groups in NCT06635538
Study groupRoleWhat they receive
Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1ExperimentalNot described
Receives: Drug: Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1; Drug: Clomiphene Citrate (CC) 100 mg/day from D1; Diagnostic Test: Monitoring cycle

What is being measured

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

  1. Estradiol

    Estradiol levels

    Measured: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval

  2. Progesterone

    Progesterone levels

    Measured: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval

  3. Follicle stimulating hormone (FSH)

    FSH levels

    Measured: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval

  4. Luteinizing hormone (LH)

    LH levels

    Measured: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval

Secondary outcomes (7)

  1. Days of stimulation

    Measured: 7 -20 days from initiation of ovarian stimulation

  2. Number of oocytes retrieved (COCs)

    Measured: 7 -20 days from initiation of ovarian stimulation

  3. Number of MII oocytes

    Measured: 7 -20 days from initiation of ovarian stimulation

  4. Follicular Output Rate (FORT)

    expressed as the ratio between the total number of oocytes retrieved at oocyte pick-up and the number of antral follicles available at the start of stimulation

    Measured: 7 -20 days from initiation of ovarian stimulation

  5. Follicle-to-oocyte index (FOI)

    expressed as the ratio between the total number of oocytes retrieved at oocyte pick-up and the number of antral follicles available at the start of stimulation

    Measured: 7 -20 days from initiation of ovarian stimulation

  6. Cancellation rate

    Measured: 7 -20 days from initiation of ovarian stimulation

  7. Ovarian hyperstimulation syndrome (OHSS) rate

    Measured: Until 15 days after punction

Timeline

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

  1. First posted10 Oct 2024
  2. Study start31 Oct 2024
  3. Primary completion11 Nov 2025
  4. Study completion11 Nov 2025

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06635538
Sponsor's protocol ID
FSD-ONE-2024-09
Acronym
One-shot
Status last verified
Sep 2026
First submitted
7 Oct 2024
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Martinez F, Racca A, Rodriguez I, Polyzos NP. Ovarian stimulation for oocyte donation: a systematic review and meta-analysis. Hum Reprod Update. 2021 Jun 22;27(4):673-696. doi: 10.1093/humupd/dmab008.

    PubMed 33742206

  • 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

  • Fares FA, Suganuma N, Nishimori K, LaPolt PS, Hsueh AJ, Boime I. Design of a long-acting follitropin agonist by fusing the C-terminal sequence of the chorionic gonadotropin beta subunit to the follitropin beta subunit. Proc Natl Acad Sci U S A. 1992 May 15;89(10):4304-8. doi: 10.1073/pnas.89.10.4304.

    PubMed 1374895

  • Glasier AF, Irvine DS, Wickings EJ, Hillier SG, Baird DT. A comparison of the effects on follicular development between clomiphene citrate, its two separate isomers and spontaneous cycles. Hum Reprod. 1989 Apr;4(3):252-6. doi: 10.1093/oxfordjournals.humrep.a136882.

    PubMed 2497133

  • Practice Committee of the American Society for Reproductive Medicine. Use of clomiphene citrate in infertile women: a committee opinion. Fertil Steril. 2013 Aug;100(2):341-8. doi: 10.1016/j.fertnstert.2013.05.033. Epub 2013 Jun 27.

    PubMed 23809505

  • Kerin JF, Liu JH, Phillipou G, Yen SS. Evidence for a hypothalamic site of action of clomiphene citrate in women. J Clin Endocrinol Metab. 1985 Aug;61(2):265-8. doi: 10.1210/jcem-61-2-265.

    PubMed 3924949

  • Dickey RP, Holtkamp DE. Development, pharmacology and clinical experience with clomiphene citrate. Hum Reprod Update. 1996 Nov-Dec;2(6):483-506. doi: 10.1093/humupd/2.6.483.

    PubMed 9111183

  • Teramoto S, Kato O. Minimal ovarian stimulation with clomiphene citrate: a large-scale retrospective study. Reprod Biomed Online. 2007 Aug;15(2):134-48. doi: 10.1016/s1472-6483(10)60701-8.

    PubMed 17697488

  • Messinis IE, Templeton A. Blockage of the positive feedback effect of oestradiol during prolonged administration of clomiphene citrate to normal women. Clin Endocrinol (Oxf). 1988 Nov;29(5):509-16. doi: 10.1111/j.1365-2265.1988.tb03700.x.

    PubMed 3150950

  • Melo AS, Paula CTV, Santos TLD, Faria VAC, Rufato MAF, Barboza RP, Barreto J. Corifollitropin alpha, clomiphene citrate and dydrogesterone without daily gonadotrophin: a new option of a friendly protocol for high-responder oocyte donors. JBRA Assist Reprod. 2022 Apr 17;26(2):315-320. doi: 10.5935/1518-0557.20210082.

    PubMed 34672261

Questions about this trial

What is this clinical trial studying?

A study testing Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1, Clomiphene Citrate (CC) 100 mg/day from D1 and Monitoring cycle in people with Infertility, Female, run by Fundación Santiago Dexeus Font at 3 sites 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 4 inclusion and 0 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 8 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 3 sites 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?

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?

Estradiol (time frame: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval). The study lists 4 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 NCT06635538, 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 8 Sep 2026.

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