刺激排卵後半階段補充LH對於試管嬰兒懷孕率並無明顯助益

刺激誘導排卵COH後半階段(M7-14)補充LH對於試管嬰兒取卵品質，胚胎品質，懷孕率似乎並無明顯助益

http://humrep.oxfordjournals.org/content/23/2/427.full

Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitrofertilization. A multicentre, prospective, randomized, controlled trial

1. A. NyboeAndersen1,10, 
2. P. Humaidan2, 
3. G. Fried3, 
4. J. Hausken4, 
5. L. Antila5,
6. S. Bangsbøll1, 
7. P.E. Rasmussen6, 
8. S. Lindenberg7, 
9. H. Ejdrup Bredkjaer8 and
10. H. Meinertz9 The Nordic LH study group9

+Author Affiliations

1. ¹The Fertility clinics 4017, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark
2. ²Skive Hospital, Skive, Denmark
3. ³Karolinska University Hospital, Stockholm, Sweden
4. ⁴Haugesund Hospital, Haugesund, Norway
5. ⁵The Family Federation of Finland, Turku, Finland
6. ⁶Odense University Hospital, Odense, Denmark
7. ⁷Herlev University Hospital, Copenhagen, Denmark
8. ⁸Holbæk Hospital, Holbæk, Denmark
9. ⁹Hvidovre Hospital, Copenhagen, Denmark

1. ¹⁰Correspondence address. Tel: +453-5451315/4976; Fax: +453-5454946; E-mail:anyboea@rh.hosp.dk

 

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Abstract

BACKGROUND The purpose of this multicentre, multinational trial was to study whether rLH supplementation to recombinant FSH (rFSH) during the late follicular phase increased pregnancy rates.

METHODS After down-regulation with nafarelin, 526 women were randomized on Day 1 of stimulation to use either rFSH (Gonal-F) alone (n = 261) or to continue after Day 6 of stimulation with both rFSH (Gonal-F) and rLH (Luveris) (n= 265) from Day 6. The starting dose of rFSH was 150–225 IU/day according to age below or above 35 years.

RESULTS Ongoing pregnancy rate at week 10–12 was 28.7% after rFSH alone and 27.2% after rFSH + rLH. This showed no evidence of a difference. Administration of rLH significantly (P< 0.001) increased serum LH. Ongoing pregnancy rates in patients with low LH levels (<33 percentile) on Days 1 and 6 of stimulation showed no difference between the group treated with rFSH only (23.9% low Day 1 LH; 22.1% low Day 6 LH) versus rFSH + rLH (25.0% low Day 1 LH; 28.9% low Day 6 LH).

CONCLUSIONS Supplementing rFSH with daily doses of 75–150 IU of rLH during the second half of the follicular phase showed no evidence of increasing the ongoing pregnancy rates in the general population. (ClinicalTrials.gov, trial number: KF02-035/03).

Table IV.

Days of treatment, doses of rFSH, number of follicles, oocytes, embryos and pregnancies in patients >35 years of age.

		rFSH alone, N = 51	rFSH + rLH, N = 49	P-values	df
Initiated cycles, n (%)		51 (100)	49 (100)
Oocyte retrieval, n (%)	Yes	50 (98.0)	44 (89.8)	0.108a
No	1 (2.0)	5 (10.2)
Transfers, n (%)	Yes	46 (90.2)	41 (83.7)	0.384a
	No	5 (9.8)	8 (16.3)
Patients with change dose of rFSH from Day 6, n (%)	Increase	22 (43.1)	22 (44.9)	0.975b	2
	Unaltered	21 (41.2)	20 (40.8)
	Decrease	8 (15.7)	7 (14.3)
Total dose in IU of rFSH, (mean, SD)		2596.3 (478.9)	2703.6 (883.2)	0.450c	98
Days of stimulation (day of hCG), (mean, SD)		11.2 (1.5)	11.3 (2.2)	0.809c	98
Follicles ≥10 mm (day of hCG), (mean, SD)		10.3 (4.9)	9.9 (6.6)	0.736c	90
Follicles ≥17 mm (day of hCG), (mean, SD)		4.6 (3.7)	4.8 (4.0)	0.836c	94
Diameter (mm) of leading follicle, (mean, SD)		18.8 (1.6)	19.2 (2.4)	0.304c	93
Oocytes aspirated, (mean, SD)		9.3 (4.2)	8.5 (5.9)	0.471c	92
Embryos transferred (mean, SD)*		1.7 (0.5)	1.7 (0.5)	0.900c	85
Embryos cryopreserved, (mean, SD)		1.3 (1.7)	1.1 (3.1)	0.703c	95
Intrauterine ‘clinical’ pregnancy (at least one gestational sac), n (%)		18 (35.3)	14 (28.6)	0.524a
Number of gestational sacs (n)		24	18
Number of embryos transferred (n)		78	69
Implantation rate (mean, SD) (sacs/embryos transferred)		0.29 (0.402)	0.26 (0.41)	0.724c	84
Number of gestational sacs with live fetus (n)		21	14
Live implantation rate (mean, SD) (sacs with live fetus/embryos transferred)		0.26 (0.36)	0.22 (0.37)	0.600c	85
Number of patients with at least one live gestation at seventh week, n(%) [CI]d		18 (35.3) [22.4; 49.9]	12 (24.5) [13.3; 38.9]	0.279a
Number of patients with live fetus, n (%)d	One fetus	15 (83.3)	9 (75.0)	0.583b	1
	Two fetuses	3 (16.7)	3 (25.0)
Ongoing live gestation at 12th week, n (%) [CI]d		17 (33.3) [20.8; 47.9]	8 (16.3) [7.3; 29.7]	0.065a

• ^aFisher's exact test; ^bCMH test for general association; ^cANOVA/ANCOVA on the raw data; ^don all pregnancy end-points the demoninator is started cycles (51 and 49, respectively). *calculated based on the subjects with at least one embryo transferred.