Clinical trial NCT01112111: A Novel Stimulation Protocol and the Conventional Low Dose Step-up and Step Down Regimens
Official title: Conventional Step-up, Step Down and a Novel Stimulation Regime in Controlled Ovarian Stimulation of Older Than 30 Years PCOS Patients Undergoing IVF- A Prospective Randomized Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PCOS
Lead sponsor: Genesis Center for Fertility & Human Pre-Implantation Genetics
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 225
Sex: ALL
Minimum age (years): 30
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PCOS is defined as the presence of polycystic ovaries, described as enlarged under US with more than 10 cysts (2 and 8 mm) in mean diameter and symptoms of oligomenorhrea/ amenorhea, high LH/FSH ratio, obesity, hyperandrogenism hirsuitism and acnes), and withdrawal bleeding after administration of progesterone. All women had either failed to ovulate after receiving a maximum daily dosage of 100-150 mg of clomiphene citrate for 5 days or failed to conceive after at least three ovulatory cycles using CC or gonadotropin treatment. Other inclusion criteria included: patients between 30 and 36 years old with patent fallopian tubes, no previous IVF attempts, and nortmo-spermic partners.

Brief summary: This study is designed to compare the efficacy of a novel stimulation protocol with the conventional low dose step-up and step down regimens in older than 30 years PCOS patients undergoing in vitro fertilisation. The novel regime was proposed under the basis of the combined effectiveness of the two standard protocols to induce a uniform follicular growth and forms a continuation to the author's previously published results examining a similar approach in younger PCOS candidates. In total 225 patients have been recruited for this study. The stimulation protocol will be assigned under the basis of prospective randomization using sealed and numbered envelopes. All patients will be down regulated using a desensitisation agent administered on day 2 of spontaneous or induced withdrawal bleeding. The initial dosage in the low dose step-up regimen (group A) will be 150 IU/d of FSH for the first 6 days followed by an increase of 75 IU thereafter. In the step-down regimen (group B) patients will administer a starting dose of 300 IU/d of FSH for the first 3 days followed by a decrease to 225 IU/d for the next 3 days. This dosage will be further decreased to 150 IU/d or sustained at 225 IU (according to the initial response) until the day of the hCG injection. Group C, patients received 225 IU on day 1 followed by a decrease to 150 IU on day 2. On day 3 the dosage will be increased back to 225 IU. This alternation of injection dosage will be followed until day 6. According to the initial ovarian response the dosage will be sustained at 225 IU/d or 150 IU/d until the day of the hCG injection. The 10,000 IU hCG will be administered when at least two follicles had reached a mean diameter of 18 mm and the serum E2 levels were consistent with the ultrasound findings. Egg retrieval will be undertaken at 35 hours after the administration of the hCG injection. Oocytes recovered will be inseminated 4 hours post egg collection. Patients will receive 3 embryos on the third day of development. The luteal phase will be supported by progesterone suppositories starting on the day of the egg collection. A positive outcome will be detected by a serum β-hCG analysis 13 days after embryo replacement. The presence of a fetal heart pulse on ultrasound 3 weeks later confirmed a clinical pregnancy.


Eligibility criteria: Inclusion Criteria:

* Failure to ovulate after CC treatment

  * Over than 30 years of age No Previous IVF attempts
* Patent Fallopian Tubes
* Normo-spermic partners

Exclusion Criteria:

* Secondary Infertility
* Younger than 30 years
* Older than 36 years
* Other infertility cause

Primary outcomes:
measure: Pregnancy Rate
timeFrame: The primary outcome measure will be assessed upon completion of the study estimated to September 2010
Secondary outcomes:
measure: Ovarian Response
timeFrame: The secondary outcome measure will be assessed upon completion of the controlled ovarian stimulation and the egg collection procedures. This parameter will be made known at least 5 weeks prior to the primary outcome mesure being availablle
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: Genesis Centre for Fertility and Human Pre-implantation Genetics
Study officials:
References: