Number of Fertilized Oocytes (2 Pronuclei [PN])
| Group | Value (2PN oocytes) | Spread |
|---|---|---|
| AS900672-Enriched 50 Mcg | 7.0 | 4.7 |
| AS900672-Enriched 100 Microgram (Mcg) | 8.7 | 4.9 |
| AS900672-Enriched 150 Microgram (Mcg) | 9.2 | 6.0 |
| Follitropin Alfa 150 IU | 6.7 | 4.2 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)
NCT00505752Jan 2007 to Sept 2008
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection \[IVF/ICSI\]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female \[RFF\] Pen) in regards to the number of fertilized oocytes.
Experimental
AS900672-Enriched 50 mcg
Experimental
AS900672-Enriched 100 mcg
Experimental
AS900672-Enriched 150 mcg
Active comparator
Follitropin alfa 150 IU
Outcomes the sponsor listed as primary.
Number of Fertilized Oocytes (2 Pronuclei [PN])
Time frame · Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}])
Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.
Percentage of Participants With Clinical Pregnancy
Time frame · Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])
Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (2PN oocytes) | Spread |
|---|---|---|
| AS900672-Enriched 50 Mcg | 7.0 | 4.7 |
| AS900672-Enriched 100 Microgram (Mcg) | 8.7 | 4.9 |
| AS900672-Enriched 150 Microgram (Mcg) | 9.2 | 6.0 |
| Follitropin Alfa 150 IU | 6.7 | 4.2 |
| Group | Value (Percentage of participants) |
|---|---|
| AS900672-Enriched 50 Mcg | 39.1 |
| AS900672-Enriched 100 Microgram (Mcg) | 40.8 |
| AS900672-Enriched 150 Microgram (Mcg) | 35.2 |
| Follitropin Alfa 150 IU | 43.8 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| AS900672-Enriched 50 McgSingle injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to \[\>=\] 18 millimeter \[mm\], two or more additional follicles with a diameter of \>= 16 mm, and Estradiol \[E2\] levels were approximately 150 picogram per milliliter \[pg/mL\] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days. | – | 5 / 132 | 90 / 132 |
| AS900672-Enriched 100 Microgram (Mcg)Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days. | – | 5 / 128 | 85 / 128 |
| AS900672-Enriched 150 Microgram (Mcg)Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days. | – | 4 / 128 | 84 / 128 |
| Follitropin Alfa 150 IUFollitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days. | – | 6 / 132 | 82 / 132 |
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