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One-shot Ovarian Stimulation Protocol (One-shot)

ConditionInfertility, Female
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorFundación Santiago Dexeus Font

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1

    Drug

    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 D1

    Drug

    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 cycle

    Diagnostic test

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Estradiol

Estradiol levels

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
2

Progesterone

Progesterone levels

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
3

Follicle stimulating hormone (FSH)

FSH levels

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
4

Luteinizing hormone (LH)

LH levels

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

Secondary outcomes

1

Days of stimulation

Time frame
7 -20 days from initiation of ovarian stimulation
2

Number of oocytes retrieved (COCs)

Time frame
7 -20 days from initiation of ovarian stimulation
3

Number of MII oocytes

Time frame
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

Time frame
7 -20 days from initiation of ovarian stimulation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación Santiago Dexeus Font

Lead sponsor

Source ClinicalTrials.gov
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