Clinical trial NCT03356964: Step Down FSH Approach and Late Follicular Phase in Progesterone Level
Official title: Impact of Step-down Approach During Late Follicular Phase in Recombinant FSH-stimulation Dosage for IVF on Progesterone Level on the Day of Final Oocyte Maturation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Progesterone Resistance
Keywords: endometrial receptivity progesterone elevation
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
Collaborators: name: Merck Serono International SA
First posted: 2017-11-29
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Step-down approach and late follicular phase progesterone level

Detailed description: The study will be performed using the stimulation medication Gonal-F which is a recombinant FSH-preparation. Due to application as pen-device, it allows reduction of the stimulation dosage in steps of 12.5IU.

It is important to evaluate the dynamics of progesterone-rise after final oocyte maturation, as this dynamic might also have an influence on the receptivity of the endometrium.

Eligibility criteria: Inclusion Criteria:

* Primary / secondary infertility with the indication for IVF/ICSI
* Patients age 18 - 40 years
* 60 kg up to and including 90 kg
* BMI of 18-32 kg/m2
* Menstrual cycle length of 24-35 days

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

Exclusion criteria:

* presence or history of an endocrine abnormality
* abnormal outcome of blood biochemistry or hematology
* relevant ovarian-, tubal- or uterine-pathology that could interfere with the ovarian stimulation treatment
* history of ovarian hyper-response (more than 30 follicles ≥ 11 mm) or ovarian hyper-stimulation syndrome (OHSS), polycystic ovary syndrome (PCOS)
* History of poor ovarian response, according to the Rotterdam-criteria (Ferrarretti et al.)
* ovarian reserve parameter, indicating the risk of poor ovarian response (AFC \< 5 and AMH \< 0,5ng/ml) (14)

Primary outcomes:
measure: Impact of dose reduction in recFSH for IVF on the progesterone level.
timeFrame: 1year and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: IVI Middle East Fertilty Clinic
Study officials:
affiliation: ART Fertility Clinics LLC
name: Human Fatemi
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
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citation: Griesinger G, Mannaerts B, Andersen CY, Witjes H, Kolibianakis EM, Gordon K. Progesterone elevation does not compromise pregnancy rates in high responders: a pooled analysis of in vitro fertilization patients treated with recombinant follicle-stimulating hormone/gonadotropin-releasing hormone antagonist in six trials. Fertil Steril. 2013 Dec;100(6):1622-8.e1-3. doi: 10.1016/j.fertnstert.2013.08.045. Epub 2013 Sep 29.
citation: Kyrou D, Al-Azemi M, Papanikolaou EG, Donoso P, Tziomalos K, Devroey P, Fatemi HM. The relationship of premature progesterone rise with serum estradiol levels and number of follicles in GnRH antagonist/recombinant FSH-stimulated cycles. Eur J Obstet Gynecol Reprod Biol. 2012 Jun;162(2):165-8. doi: 10.1016/j.ejogrb.2012.02.025. Epub 2012 Mar 17.
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